Increasingly, that future doesn’t just look like roads and buildings. It looks like regenerative medicine, advanced manufacturing and biomedical devices that blur the line between engineering and human health. That distinction matters.

The recent past

Over the past two decades, women have made measurable – and meaningful – gains in engineering. Undergraduate enrolment has climbed steadily, reaching just over 25 per cent nationally in 2023. In some disciplines – particularly biosystems, environmental and chemical engineering – women now represent a significant share, in some cases approaching or exceeding 40-50 per cent.

Notably, many of these gains are concentrated in fields that sit at the intersection of engineering and life sciences. Biomedical engineering, regenerative medicine, and biofabrication have emerged as areas where women are not only participating, but shaping the direction of research and innovation. From tissue engineering and 3D bioprinting to implantable devices and precision drug delivery, these fields are redefining what engineering looks like and who sees themselves in it.

In other words, the pipeline is no longer the problem it once was. But beyond graduation, the story becomes more complicated.

Despite increased participation at the entry level, women still make up only about 15 per cent of engineering professionals in Canada, according to a report from the Diversity Institute at Toronto Metropolitan University (TMU). The drop-off is real and persistent. In Ontario, for example, women represent roughly one in five engineering graduates, but are less likely than men to end up working in engineering roles at all, according to a report by Wendy Cukier for the Council of Canadian Academies (CCA) on the “State of equity, diversity, and inclusion within Canada’s science, technology and innovation ecosystem.”

This is the “leaky pipeline” we keep talking about. And it leaks at multiple points. There are the familiar factors: workplace culture, bias in hiring and promotion, and the disproportionate burden of unpaid care work. Many women still describe engineering environments as legacy systems that are slow to change, and often shaped by long-standing networks that are difficult to access from the outside, as per the TMU report above.

Not surprisingly, compensation is still an issue. By 2021, the gender pay gap for engineering graduates in Canada had widened significantly, with women earning roughly 75 per cent of what their male counterparts earn on average, says the CCA. That gap compounds over time, influencing everything from career mobility to leadership opportunities.

And leadership is where the gap becomes most visible.

Again from TMU, women hold only about 18 per cent of engineering management roles. In academia, the numbers are similar or worse at senior levels. Even in research-heavy fields like biomedical engineering, where participation is higher, women are less likely to occupy the most senior, decision-making positions or to be recognized as lead authors on major publications. That means representation is improving at the front end, but influence remains uneven.

The present and the future

Engineering is in the middle of a transformation. For example, advanced manufacturing is becoming more automated, data-driven and digitally integrated. Biomedical engineering is converging with artificial intelligence (AI) to enable everything from predictive diagnostics to personalized treatment design.

Jobs are changing and will continue to do so, but AI opens up opportunities for new ones, some that are obvious and some that we haven’t even imagined yet. When the Internet began reshaping the field of public relations, social media managers didn’t yet exist. The same will happen as a result of AI; fortunately, humans are resilient and we will adapt. Engineering jobs are not disappearing so much as evolving, especially at the entry level.

If fewer traditional entry-level roles exist, access to meaningful early-career experience becomes more competitive, which could amplify existing inequities. Those with stronger networks, better mentorship, or fewer systemic barriers will have an advantage. Without intentional intervention, the same gaps we see today in jobs, salaries, and leadership could widen.

On the bright side, fields like regenerative medicine and biomedical engineering are still being somewhat defined. Advanced manufacturing is being rebuilt around digital tools and new workflows. These are not legacy systems in the same way as traditional engineering disciplines and that offers a real opportunity to build them differently.

Ideally, we will see more inclusive hiring practices and transparent compensation structures – something that the Government of Ontario now requires. There’s also an opportunity to develop more accessible leadership pathways and mentorship can really help those at the early-career stage.

Getting women into engineering matters, but ensuring they stay, advance and lead is equally important.

Today’s engineering jobs are complex and solving them will require the full spectrum of talent (i.e. representation).

National Engineering Month is a moment to celebrate progress, but it’s also a moment to be honest about what remains unfinished. The question is not just what we are building but who gets to build it. As a mother of a daughter who is about to graduate with an engineering degree, that matters a lot.

Are you ready to celebrate engineers? Watch this stand-up comedy routine by engineer Don McMillan.

Image: Freepik

The use of stem cells in wound healing is not novel, as skin stem cells have been studied for decades for their regenerative abilities. However, over the last few years, therapies reliant on stem cells and their by-products have been rapidly integrated and made mainstream for skin rejuvenation. Products like Platelet Rich Plasma (PRP) have been fully commercialized and are available on the shelves for dermatological procedures, some of which include walk-in appointments.

In view of their unique properties, skin stem cells have been employed in the treatment of several dermatoses (any disease of the skin, nails and hair not accompanied by inflammation), including systemic sclerosis, systemic lupus erythematosus (SLE), scleromyxedema, alopecia, Merkel cell carcinoma, pemphigus vulgaris, psoriasis, wound healing, epidermolysis bullosa and even aesthetic medicine, with variable success.

But besides curative treatment or management of complex conditions, dermatologists utilize them to revitalize and improve skin texture, elasticity and appearance, to stimulate collagen production and reduce fine lines and wrinkles. These functions, highly sought after by a great majority of people, have turned the tide in dermatology and aesthetic medicine. Before we proceed, let’s first explore the application of stem cells across a variety of non-aesthetic dermatological cases.

Hair follicle and sebaceous gland regeneration

In this study, researchers showed that two types of skin cells, namely epidermal stem cells (Epi-SCs) and skin-derived precursors (SKPs), can reconstitute functional hair follicles and oil glands. When these cells were mixed in a gel and placed into skin wounds on mice, the Epi-SCs formed new skin and hair, while the SKPs helped build the hair’s root structure. Remarkably, even human scalp-derived Epi-SCs and SKPs were able to grow new hair.

Medical hair loss conditions like androgenetic alopecia and alopecia areata have long been issues of concern. But mesenchymal stem cells (MSCs), adipose-derived stem cells (ADSCs), and stromal vascular fraction (SVF) release growth factors that “wake up” dormant hair-follicle stem cells, nourish dermal papilla cells, and promote new blood vessel formation. Together, those processes help bring thin, inactive follicles back to life.

A double-blind randomized trial of ADSC conditioned media with minoxidil and multiple Phase I/II studies report increases in hair density and thickness over the control trial. Meta-analyses suggest consistent benefit signals, though variance in preparation methods and outcome measures remains a challenge. Safety profiles have generally been acceptable, but long-term data are still emerging.

In practice, this service is already being offered in clinics by extracting the patient’s own fat cells through liposuction, then injecting them into the scalp (i.e., an intradermal injection). Other therapies include topical solutions and combinations with standard treatments like minoxidil and finasteride.

Chronic wounds and diabetic foot ulcers

Few areas illustrate the clinical urgency of regeneration as clearly as chronic ulcers, which are usually difficult to cure and prone to recurrence. Diabetic foot ulcer is a major cause of amputation amongst patients with diabetes worldwide, with a significant proportion of cases attributed to it. MSCs, however, have been shown to be successful in this regard. They accelerate re-epithelialization, stimulate angiogenesis, and reduce local inflammation and fibrosis.

Recent clinical studies and systematic reviews have found that patients treated with adipose-derived MSCs experience faster healing and better long-term outcomes. Several ongoing clinical trials, such as STEMFOOT (NCT05595681), are investigating their role further. The evidence is promising, such as positive signals on wound closure rates and time-to-heal, though researchers note that larger, standardized studies are still needed.

In clinics, MSCs can be applied directly to the wound site through local injections, scaffolds, or even special “cell sheets.” Some therapies use only the conditioned media (i.e., the nutrient-rich solution produced by the stem cells) to stimulate healing without introducing the cells themselves.

Atopic dermatitis and inflammatory dermatoses

In chronic inflammatory skin conditions like atopic dermatitis, the immune system is often overactive, producing too many inflammatory signals and damaging the skin barrier. MSCs can help restore balance. They modulate the immune response, tone down Th2-driven inflammation and cytokine production. This, in turn, improves skin barrier function and supports healthier skin regeneration.

In one clinical trial, adults with moderate to severe atopic dermatitis received MSCs derived from umbilical cord blood. The treatment was safe and led to measurable symptom relief. Follow-up studies have echoed these findings, reporting better skin-barrier function and reduced inflammation. While large-scale randomized trials are still limited, small trials and open-label studies suggest that MSC-based therapies could one day complement or even replace conventional immunosuppressive treatments.

Autoimmune blistering and systemic autoimmune skin disease

Some autoimmune diseases are so severe that standard therapies can’t control them, especially those affecting the skin, such as systemic sclerosis, pemphigus vulgaris and severe refractory SLE. In extreme cases, the complications that arise can even kill patients.

For these diseases, doctors may use autologous hematopoietic stem cell transplantation (HSCT), a powerful treatment designed to “reset” the immune system by removing the patient’s faulty immune cells and replacing them with healthy stem cells from their own body. Studies have shown that for autoimmune skin diseases, this can significantly alleviate skin symptoms and improve the chances of survival.

Major clinical trials, such as the UPSIDE trial, continue to refine when and how HSCT should be used. For now, it remains an option only for the most resistant, high-risk cases due to its intensity and potential risks and complications.

Vitiligo and pigmentary disorders

Stem cell-based therapies restore lost pigmentation by locally repopulating the skin with melanocytes. For years, doctors have successfully used a patient’s own (autologous) cultured or mixed melanocyte-keratinocyte cells to restore skin colour. This treatment is an outpatient procedure, offered in clinics, with little to no downtime. Today, newer regenerative approaches are exploring melanocytes taken from hair follicles and other stem cell-based sources.

The growing use of PRP

Among regenerative tools, PRP has achieved the widest acceptance. Platelet Rich Plasma is an autologous blood product able to harness the body’s own healing mechanisms. Containing growth factors and cytokines, they are able to enhance collagen formation and tissue regeneration. Most applications concentrate platelets from the donor’s blood and apply them to target areas with dermatological concerns like scarring, dyspigmentation, hair loss and skin rejuvenation. PRP has expanded into mainstream aesthetic medicine and has become a treatment modality in aesthetic clinics all over the world. The global market for PRP is projected to reach US$1.936 billion by 2030.

PRP, whether topical or intradermal, is used as an adjunct to other treatment modalities like laser, stem cell therapy, and microneedling to improve clinical outcomes. For acne scarring, microneedling with intradermal PRP injections is a procedure with established efficacy.

Stem cells and the anti-aging campaign

We’ve seen the trend, celebrities who don’t age or appear to get younger looking, and the amplified focus on anti-aging. Besides being the golden child, stem cells are quickly becoming the frontrunner in the race against time.

The skin contains many different cells, responsible for replacing old and damaged cells. There are melanocytic stem cells, dermal stem cells and adipocytic cells. This innate regenerative capacity diminishes over time and is known as intrinsic aging. Cell renewal continues to slowly regress until it ceases. Keratinocytes and fibroblasts accumulate over time and this increase causes the hardening of tissues, wrinkling, and an overall increase in the rate of aging.

Skin aging is also observed in another way: extrinsic aging. Extrinsic aging is the premature aging of the skin that develops due to various time-independent factors. Aging can occur due to environmental factors such as climatic conditions, air pollution, the sun’s rays, or inadvertent use of damaging products in contact with the skin. Exposure to UV rays causes free radical formation and damages the collagen tissue and elastin network. Thus, cell renewal decreases and hyperpigmentation, dryness and wrinkles occur.

The collagen and elastin stores begin to get depleted and production drops, causing skin elasticity to drop, fine lines to form, wrinkles, hyperpigmentation and dry skin. There is skin thinning due to the decrease in cell renewal.

Canada’s evolving role in regenerative dermatology

Canada occupies a prominent place in this global trend. With its strong academic research ecosystem, cautious but enabling regulatory environment, and growing clinical adoption, Canada has become both a testing ground and a translational bridge for regenerative technologies.

Universities like McGill and McMaster and pharma companies like AMGEN have helped move regenerative science from bench to clinic by emphasizing manufacturing quality, clinical-grade production, and real-world application. In dermatology, this has translated into growing collaboration between researchers, clinicians, and industry partners working to validate therapies beyond proof-of-concept. Canadian dermatology clinics are increasingly incorporating PRP protocols aligned with evidence-based standards, while academic centres contribute to early-stage research on MSC-derived products and other stem cell technologies.

A quiet revolution

Beauty might be only skin deep, but it is the first thing people see. Widespread adoption of stem cells for treating skin diseases and enhancing people’s cosmetic appearance later in life will spur further development. More investments into stem cell research will make them useful not only in beauty treatments, but also to cure critical diseases afflicting people around the world.

A CCRM scientist looking through a microscope

Somehow we are already into March, and spring – at least in some places – feels close by. To catch you up, I’ve put together a recap of some of the research that scientists were buzzing about in the field of regenerative medicine from 2025; I cover the good, the bad, and the controversial. All of these stories were first highlighted in Regenerative Medicine News Under the Microscope, so consider this a greatest-hits compilation. These investigations just continue to get bigger, and it’s very encouraging to think that we’re finally making some progress in bringing what could be game-changing treatments out of labs and to people who really need them.

Let’s jump right in! In no particular order:

1. Parkinson’s disease

Specifically, work by Bluerock Therapeutics, which announced that their stem cell therapy for Parkinson’s would be moving to Phase III. It was found to be safe, and there are hints of potential efficacy, but we now get to find out how effective it really is with more patients trying out the treatment.

2. Good news for epilepsy

Another stem cell therapy that jumped to Phase III this past year was Neurona Therapeutics’ solution for epileptic seizures that don’t really respond to medications. This one’s particularly interesting because we finally get to test theories that have been investigated in vitro and in animals for years. In its simplest form, the theory is that epilepsy is likely caused by an imbalance between the chemicals in the brain that amplify or increase electrical activity, and the chemicals that dial down or inhibit activity. It continues that epilepsy patients may not have enough of the dampening chemical, and there’s just too much runaway electricity. Neurona’s cell therapy introduces more cells into the brain that produce the inhibitory chemical, just to dial things down a bit, and again it was looking very promising in the Phase I/II trial.

3. Vision repair

Optogenetics is one of my specialties, so stories like these are always particularly exciting to me. In 2025, there was a very elegant application of optogenetics for vision loss. Patients received a genetic therapy involving a lab-created, light-sensitive protein. I would so encourage our readers to go and watch the videos included in the published paper; it was really inspiring to see someone go from not being able to detect where a light is in a room to actually being able to walk straight towards it.

4. Healing damaged corneas with one’s own stem cells

This story is really USA-specific. Researchers conducted a Phase I/II clinical trial of the first xenobiotic-free, serum-free, antibiotic-free manufacturing protocol developed in the U.S.

While this paper is exciting, I just wanted to highlight that using healthy limbal stem cells from one eye to heal a damaged cornea in the other is not new, and the authors don’t claim it to be so, yet the news on this story was largely making it out to be an entirely novel procedure; I thought this was interesting. In fact, we’ve been doing it here in Canada for a while. The actual novelty offered by this protocol is that manufacturing guidelines in the U.S. are different, and that’s what’s preventing autologous limbal stem cell transplants in their current form from being used by our Southern neighbours… until now, potentially. The researchers behind this paper modified various in vitro steps to adhere to the U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practices, meaning this treatment might soon be accessible to patients in the U.S. – a great accomplishment.

5. Stem cells for diabetes

Vertex Therapeutics, which also manufactures Casgevy – the gene-editing medicine for sickle cell disease – has also developed a cell therapy for severe type 1 diabetes, and there are people who have participated in their clinical trial who are now able to make their own insulin. The data was published in 2025.

Significant downside: Patients receiving this therapy also need to take immunosuppressants because the cell therapy comes from someone else. To get around this, Vertex was also working on a different version of this treatment where the transplanted cells could be encapsulated in a device that would protect them from the immune system. Unfortunately, it was announced last year that their device failed in a separate clinical trial so, for now, immunosuppression is the only option.

6. Alzheimer’s disease

Longeveron published its Phase IIa CLEAR MIND trial with positive results, testing a mesenchymal stem cell (MSC) therapy for mild Alzheimer’s disease (AD). This was an intravenous treatment created using bone marrow-derived MSCs.

MSCs are being tested for many different diseases because they seem to be really adept at modulating the immune system and managing inflammation (and as you likely know, what disease these days doesn’t involve inflammation). Their goal was to slow the clinical progression of AD and, importantly, immunosuppressive drugs weren’t required in this trial despite the fact that the cells did come from donors. This is because MSCs are immunoprivileged, and they don’t trigger the immune system in the same way other cells might.

A Phase II/III trial is currently in development.

7. A darker story about Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a genetic disorder that causes muscle degeneration. You can imagine how that affects everything in the body: one’s ability to move, breathe, keep the heart beating properly, all of it. A company called Sarepta Therapeutics created a one-time genetic therapy for the disease, and a few deaths in 2025 revealed that it’s really not for everyone with DMD. Patients who were walking around on their own were able to take this medicine largely without major incidents. However, a pair of patients did die after taking this medicine, and it turns out they were non-ambulatory, meaning they couldn’t walk independently. The FDA took this information and decided to restrict use of this medication to only those who could walk, and walking here appears to be a readout of disease severity. Liver failure was the cause of death, a complication of viral gene delivery. The FDA also added a warning to the label for patients with pre-existing liver issues.

Fierce Pharma has a great piece on this story if you want to learn more.

8. Onto more positive news: custom CRISPR medicines

Six months, one week, and four days.

That’s how long it took scientists to create a custom CRISPR therapy for baby KJ, who was suffering from a rare, life-threatening condition called CPS1 deficiency – short for carbamoyl phosphate synthetase I deficiency. This timeline is unprecedented, given that drug development usually takes over 10 years.

CPS1 deficiency is a genetic defect of the process by which the body metabolizes protein. What results is a buildup of ammonia in the tissue, which can be toxic (especially in the brain). Estimated to have an infant mortality rate of 50 per cent and affect just 1 in 1,300,000 people, even if the child does survive, there’s still a risk of developmental delays and intellectual disabilities.

Of course, once the baby is diagnosed, their protein consumption is often significantly restricted and nitrogen scavenging medication is usually prescribed. In KJ’s case, rather than the usual liver transplant that would follow, the research team of Musunuru et al. developed a custom CRISPR therapeutic to edit the infant’s genetic code.

To date, KJ has been stable and is consuming more protein and less medication, suggesting efficacy. However, longer follow-up will be required to assess the overall safety and determine just how well the treatment works. So far, so good!

Read more in this NIH news release. 

9. CAR T-cell therapy

As you likely know, CAR T-cell therapies available in clinics are currently ex vivo: T cells are removed from the body, upgraded in the lab, then returned to the patient.

Taking this strategy to the next level, researchers have been working on a way to upgrade T cells without removing them first. A very nice example of this was published by Hunter et al. Their team developed an in vivo genetic engineering strategy to reset the immune system and create CAR T cells in humanized mice and cynomolgus monkeys.

They use targeted lipid nanoparticles to deliver the mRNA to specific subsets of T cells.

Check out this great news piece in Nature Reviews Drug Discovery that summarizes progress in this space.

10. Cancer vaccines!

This piece wouldn’t have been complete without mention of Anixa Biosciences’ breast cancer vaccine.

Phase I enrollment wrapped up in 2025. The vaccine is a set of three shots given two weeks apart. So far, 35 women have received the vaccine.

Preliminary results suggest that the vaccine is well-tolerated and that it does indeed mobilize an immune response, so Phase II is in the works.

11. Aging

A single factor for safer cellular rejuvenation.

This paper left everyone in the scientific community very confused. A company called Shift Bioscience found a gene that they claimed lowers single-cell age and attenuates harmful signatures of multiple hallmarks of aging.

They proceed not to tell us what that gene is.

It’s really not the norm to publish a “scientific” paper that keeps the gene being studied entirely hidden. I understand that the team is treating it as a trade secret for business reasons, but asking for blind trust at any stage is unreasonable, especially in the wake of other controversies in the regenerative medicine field. I doubt the paper will get accepted into a mainstream journal as-is for this reason; it’s currently a pre-print.

It’s especially strange as a strategy because this is what patents are for. If the team can produce an intervention to manipulate the gene, they can file a patent like any other biotech company. It seems like they’re intentionally trying to spur speculation and suspense, so… moving on.

12. We’re ending on a high note with Down syndrome

CRISPR was used in vitro on human cells to correct the chromosomal abnormality (a third copy of the 21^st chromosome) that causes Down syndrome and restore cell function. This is very promising work that serves as a proof-of-concept for future therapeutic avenues.

 I hope this recap was helpful and that the year is off to a great start for you all!

Live microbes on a Petri dish prior to genetic engineering. Image: Pixabay

Microbiota-based products, supplements, or therapies can be used in combination with stem cell treatments to create a more hospitable and welcoming environment for transplanted stem cells to take hold and grow. When used in conjunction with stem cell treatments, these microbiota-based therapies are known as microbial adjuncts, non-essential but beneficial additions to the primary treatment (in this case, stem cell transplantation).

Microbial adjuncts can calm the immune system, thereby preventing unnecessary attacks on transplanted stem cells. They can be broken down into five categories: metabolites/postbiotics, live microbes/probiotics, microbiome conditioning, ex vivo stem cell priming, and bioengineered microbes. All five categories of microbial adjuncts enhance stem cell therapies by modulating the immune system, promoting stem cell proliferation and differentiation, improving engraftment, and supporting healthy tissue via signalling molecules and metabolites.

Metabolites/postbiotics

When microbes undergo metabolism, they produce what are known as “metabolites.” These are also referred to as postbiotics. They are the non-living signalling molecules and/or chemical messengers of live bacteria. Some of the most abundant microbial metabolites are short-chain fatty acids (SCFAs), such as butyrate, acetate and propionate. Gut microbes produce SCFAs when they ferment fibre. SCFAs reduce inflammation and calm the immune system by promoting regulatory T cells; this allows stem cells to grow in a healthy environment. They also influence which specific cell type stem cells will become once they differentiate.

Other metabolites include tryptophan derivatives, B vitamins and lipid mediators, amongst many others. These all play a role in immune modulation and regulation, and each has a wide range of subtle effects on the host. Because they are stable, controllable, non-living, and targetable to specific functions, metabolites are the safest type of microbial adjunct.

Live microbes/probiotics

Patients undergoing stem cell therapies can receive live microbes, rather than the metabolites of live microbes. They are generally considered less safe than metabolites due to their unstable and living nature. In immunocompromised patients, there is a risk of infection when live microbes are administered. Additionally, different species and strains have different effects on host physiology, depending on a variety of factors, some not yet elucidated.

It is unclear whether probiotic supplementation is transient or if the microbes are able to assimilate into the microbiome, altering the composition chronically rather than acutely. It might be species-specific, like if some can survive more than others through stomach acid, eventually making their way to the colon. Usually, strains of Lactobacillus and Bifidobacterium are used, as these have shown promise in clinical studies to promote stem cell proliferation and differentiation, support gut health, and reduce the risk of graft-versus-host disease (GVHD).

Microbiome conditioning

Microbiome conditioning encapsulates a variety of therapies that modulate the microbiome, ranging from diet interventions to fecal microbiota transplants. For example, increasing fibre in the diet can lead to an increased production of SCFAs, which reduce inflammation, as mentioned above. Additionally, fibre intake can be increased via prebiotic supplementation; prebiotics are non-digestible fibres that feed beneficial bacteria in the gut. An increase in these beneficial bacteria also leads to increased SCFA production. Similarly, increasing antioxidants in the diet can foster an ideal environment for stem cell proliferation and differentiation by reducing oxidative stress and supporting the metabolic functioning of the host.

Fecal microbiota transplants (FMTs) are a higher-risk intervention than diet changes. FMTs involve taking the entire gut microbiome composition of a healthy individual (via fecal matter) and transplanting the fecal matter into the patient’s colon. There is not yet a standardized procedure for FMTs, and there remain risks for infection, particularly in immunocompromised patients. However, when successful, gut health can be restored, and the risk of GVHD can be greatly reduced or even eradicated.

Microbiome conditioning interventions are personalized and patient specific. With something as complex as the microbiome, some interventions could unintentionally be doing more harm than good. More research is needed, but it is difficult to perform when microbial communities in the human gut are constantly evolving and communicating in myriad ways, with both each other and their human host.

Ex vivo stem cell priming

Ex vivo stem cell priming is treating stem cells outside the body before they are transplanted. The goal is to make them more effective once they are infused into the body. One way to do so is with microbial metabolites. For example, hematopoietic stem cells can be modulated with SCFAs to influence differentiation, which is what stem cells decide to become once transplanted. Although research for microbial priming of stem cells is still preclinical at this stage, and limited to mice, it is an exciting and trendy area.

Bioengineered microbes

The bioengineering of live microbes is currently one of the most cutting-edge niches of synthetic biology, an area of science focused on designing biological parts or entities. Some ambitious and ongoing goals of synthetic biology are creating bacteria that can digest plastic, or engineering organisms that can produce fuel. The regulation of synthetic biology is messy, however, due to the fact that bioengineering leads to genetically modified organisms (GMOs). Therefore, bioengineered microbes are far from clinical use and are likely a therapy of the future. Nonetheless, they could offer a more targeted approach than typical probiotic supplementation, as long as off-target effects are mitigated. Bacteria could be modified to produce specific metabolites that benefit stem cell treatments (i.e. bacteria that produce VEGF and thereby increase angiogenesis of mesenchymal stromal cells).

In conclusion, the microbiome can be harnessed to improve the efficacy of stem cell therapies, largely by promoting proper immune tolerance, which in turn reduces inflammation, lowers the risk of GVHD, and supports healthy tissue growth and repair. But harnessing the microbiome isn’t easy, with the exasperating complexity of microbe-microbe interactions and microbe-host interactions, usually via metabolites. It is essential that we do not underestimate or overestimate the power of synthetic biology and bioengineering of complicated microbiota compositions, as bacteria have been around for billions of years and are capable of horizontal gene transfer and rapid evolution. The immune system and the microbes that live in and on us are so intricately connected, which is what makes microbiome modulation and microbial adjuncts such a strong determinant of immune function, inflammation, and stem cell transplantation success.

Image created through ChatGPT

In 2025, cell and gene therapy (CGT) showed growing clinical familiarity even as access and reimbursement challenges persisted. Providers and payers increasingly trusted and valued CGTs, supporting the continued expansion of late-stage programs. However, startup activity remained muted amid economic uncertainty, regulatory shifts, evolving therapeutic priorities and increasingly selective investors. Even though total deal value increased, the number of deals remained low, as buyers focused on fewer transactions that closely aligned with their priorities and relied more on milestone-based payments. The EY Firepower report described 2025 as a year of “smaller, smarter” dealmaking, reflecting a more disciplined and intentional approach across the market.

What mattered most was not deal volume but where capital flowed, as investment concentrated around late-stage clinical data, regulatory inflection points and strategic partnerships that signalled de-risked science and commercial readiness.

CGT dealmaking overview by quarter in 2025

In the first quarter (Q1) of 2025, a total of 90 CGT deals were recorded, 20 per cent fewer than in the previous quarter. Despite the overall slowdown, acquisition activity rose from seven to nine deals, reflecting sustained interest in de-risked assets. From a pipeline perspective, 27 non-genetically modified cell therapy trials were initiated in Q1 with 74 per cent targeting non-oncology indications, reflecting growing interest in autoimmune and inflammatory diseases. In contrast, 79 gene therapy trials were launched, with 57 per cent focused on oncology – the highest concentration observed over the past year.

In the second quarter (Q2), overall deal volume stabilized while acquisition activity increased to 12 transactions. This trend highlighted buyers’ growing confidence in deploying capital selectively, even as funding for early-stage companies remained limited. From a pipeline perspective, Q2 showed a renewed emphasis on RNA therapeutics targeting oncology, with the highest proportion of RNA oncology trials recorded in the past two years. This shift reflected increasing confidence in RNA-based approaches beyond vaccines and infectious disease, supported by continued advances in RNA delivery technologies and a clearer line of sight to oncology-focused clinical and commercial value.

By the third quarter (Q3), deal activity rebounded to 99 transactions, driven largely by partnerships and structured deals, whereas acquisitions dropped to just three. Buyers appeared more comfortable sharing risk than committing to outright acquisitions. Scientific momentum remained strong, with 125 trials launched across gene, cell and RNA modalities, indicating continued investment in clinical development even as capital markets grew more selective.

The fourth quarter (Q4) of 2025 showed more active CGT dealmaking, with heavier use of contingent value rights and milestone-based economics as a key signal. According to GlobalData, the average milestone payment for biopharma deals increased in Q4 compared with Q3. At the same time, market sentiment improved as the XBI, a biotech stock index, rose by almost 75 per cent from earlier lows to reach its highest level since 2021.

Which therapeutic areas had the biggest deals in CGT?

Autoimmune

In vivo cell therapy clearly stood out for investors in 2025, as it removes ex vivo manufacturing bottlenecks and makes cell therapy easier to scale. AbbVie acquired Capstan Therapeutics for up to US$2.1 billion to gain its in vivo CAR T platform that engineers immune cells directly inside the body for the treatment of autoimmune diseases and cancer. AstraZeneca followed a similar approach with its US$1 billion acquisition of EsoBiotec, whose ESO-T01 platform reprograms immune cells directly in vivo.

Cardiometabolic

Expanded gene-editing deal activity in cardiometabolic disease reflects a shift toward durable, one-time in vivo genomic therapies to replace lifelong therapies. Eli Lilly’s up to US$1.3 billion acquisition of Verve Therapeutics is centred on VERVE-102, a base-editing therapy designed to permanently lower cholesterol. The deal highlights Lilly’s push to shift cardiovascular care away from lifelong dosing toward durable, single-intervention treatments.

Renal

Addressing the rare genetic disorder autosomal dominant polycystic kidney disease (ADPKD) drove Novartis’ US$1.7 billion acquisition of Regulus Therapeutics. Farabursen is a potential first-in-class oligonucleotide targeting miR-17 with preferential kidney exposure. Phase Ib clinical data showed reductions in cyst growth and kidney volume along with signals suggesting delayed disease progression in ADPKD.

Ophthalmology

Big Pharma made its strongest move into ophthalmology in 2025, where durable, single-dose therapies could replace chronic injection regimens. Eli Lilly agreed to acquire Adverum Biotechnologies in a deal valued at up to US$260 million for Ixo-vec, an intravitreal gene therapy being developed for wet age-related macular degeneration. Just weeks later, Lilly also partnered with MeiraGTx in a deal worth more than US$400 million in potential payments, gaining access to its AAV-AIPL1 program for a severe inherited retinal disease supported by early clinical data.

What to expect in CGT dealmaking in 2026

In 2026, CGT dealmaking is likely to remain highly selective, reflecting the disciplined approach seen in 2025. While innovation will continue to matter, investment decisions will increasingly be shaped by deal structure evolution, international partnerships and shifting therapeutic priorities.

Evolving capital structures

Capital structures in life sciences will continue to evolve as investment capacity aligns more closely with opportunity. Mergers and acquisitions (M&A) activity in 2026 is expected to increase, supported by stabilizing financing conditions and selectively reopening equity markets. As outlined by Amanda Frick, private equity, royalty financing and minority investments are now mainstream tools for bridging late-stage development and commercialization. These structures provide added runway and flexibility for innovators constrained by earnings-per-share considerations, without immediate dilution. This dynamic is expected to persist into 2026, with private equity remaining active across pharma technology.

China-West collaboration

Cross-border collaboration is expected to remain a central driver of CGT dealmaking in 2026, as Chinese biotechs increasingly adopt multi-regional clinical trials and attract early-stage CGT development partnerships abroad. China’s biotech dealmaking reached record levels in 2025, with more than 140 China-related licensing and investment deals announced, and activity is expected to continue rising. Without strategic collaboration, Western markets risk not only losing leadership in innovation but also delaying patient access to emerging CGT therapies.

Therapeutic expansion

CGT will continue moving beyond its early experimental phase. Base editing is expected to play a much larger role as next-generation tools reduce DNA damage and enable multiple genetic modifications simultaneously. At the same time, companion diagnostics will evolve beyond single biomarkers, with multi-omics approaches improving patient selection and accelerating trial execution – making it more realistic to pursue chronic, rare and neurological diseases. Momentum will also continue to build around off-the-shelf immune products and next-generation immunotherapies that can be manufactured and delivered at scale, rather than highly individualized treatments. Developers will face increasing pressure to move away from niche inpatient settings toward cost-constrained outpatient care models, elevating the importance of durability, pricing discipline and health economic justification.

As CGT moves into 2026, the market is shifting from a period of caution to one focused on execution and strategic focus. The message from 2025 was clear: investors backed programs with strong clinical data and a realistic path to market, not scientific promise alone. In 2026, dealmaking is likely to centre on fewer, higher-conviction transactions, supported by more flexible capital structures, stronger cross-border collaboration and a growing focus beyond oncology into more common diseases. Ultimately, the next phase of value creation in CGT will be led by teams that can turn biological breakthroughs into therapies that are scalable, durable and economically viable.

”Beginning this year, the sector is entering a very disciplined, and we believe sustainable, growth cycle,” said Tim Hunt, CEO, ARM, noting, incidentally, that it’s his fourth anniversary delivering the briefing. Mr. Hunt outlined how the sector has absorbed difficult lessons from its first commercial wave and is emerging stronger, more selective, and better aligned with patients, regulators and payers.

Image credit: Alliance for Regenerative Medicine

The difficult lessons in question were early cell and gene therapies, which struggled commercially due to factors including small patient populations, safety concerns, intensive treatment regimens, and difficulties with access and reimbursement. All of these challenges were then compounded by investment headwinds. These realities forced a period of recalibration, but the optimism and trust in the potential of these revolutionary therapies never went away. Now, as we move into 2026, two-thirds of the thirty largest companies by market capitalization are investing in the development or commercialization of cell and gene therapies, according to ARM.

The message of this year’s briefing was that companies are now adapting with greater discipline. Approaches are being refined to improve safety, streamline manufacturing, and reduce burden on patients and health systems. With many therapies in the pipeline targeting high unmet need, there is potential to reach broad patient populations with conditions like Parkinson’s, diabetes and localized prostate cancer. That’s not to say that patients with rare diseases will be left behind, however, and I’ll come back to this point.

Screenshot of Tim Hunt giving ARM’s State of the Industry briefing

Patient impact

Perhaps the clearest signal of progress comes from patients themselves. “What better starting point than our ‘North Star,’ the impact that this sector … that all of you can have when things work well: our patient community,” said Mr. Hunt, introducing patient stories including Marci McCue. Marci was the first participant in a CAR T clinical trial for multiple sclerosis, and Baby KJ became the first person to receive a bespoke CRISPR base-editing treatment that was developed and tested in under seven months, saving his life from a rare genetic metabolic disorder.

Screenshot of Tim Hunt giving ARM’s State of the Industry briefing

Patients with rare conditions like Baby KJ look set to benefit from rapidly evolving regulatory frameworks, which are adapting to accelerate approvals through platform approaches, such as the FDA’s emerging “plausible mechanism” pathway. The core idea is that once a therapy platform has a well-understood and validated biological mechanism, regulators can rely on that existing evidence when assessing new products that use the same mechanism, enabling faster review without having to re-prove how the system works each time. This approach allows highly targeted treatments to be developed and approved more quickly and at lower cost, making therapies for very small patient populations viable where they otherwise would not be.

Global competition is accelerating regulatory modernization

Much of this progress is being driven by global competition, which is acting as a powerful catalyst for system-level change. Cell and gene therapy (CGT) is now a truly global industry. In 2025, the Asia Pacific region surpassed North America in CGT clinical trial activity for the first time, driven largely by China’s policies favouring rapid initiation of early-stage trials.

Screenshot of Tim Hunt giving ARM’s State of the Industry briefing

Europe is also positioning itself more assertively. The EU Biotech Act, released in December 2025, marks a potential inflection point for the region’s CGT ecosystem. By aligning regulation, investment, and delivery, it proposes faster clinical trial starts, dedicated ATMP centres of excellence, enhanced intellectual property incentives, as well as significant new funding for early-stage companies.

“They properly recognize that the success of the sector depends on how regulation, investment, and delivery work together,” said Mr. Hunt, welcoming the EU’s shift from regulator to enabler. “The bigger point is, it’s a recognition that, in Europe, they really have to drive greater innovation to compete with North America and Asia.”

In the United States, there is a growing alignment between health policy priorities and the long-term promise of curative therapies. “They have told us repeatedly, and in many different forums, look, we believe that the Make America Healthy Again movement is highly aligned with what you guys are trying to achieve in the cell and gene therapy community,” said Mr Hunt, explaining that both share an ambition to move beyond cycles of chronic care and instead address the underlying root causes of disease. He added that this alignment is beginning to translate into action, with regulators showing greater openness to real-world evidence, more flexible development pathways, and policies designed to accelerate patient access to curative therapies, reinforcing the view that regenerative medicine is becoming an increasingly central pillar of a more sustainable health-care system.

Safety context matters and the data is reassuring

As therapies move closer to broader adoption, benefit-risk assessment has become more nuanced and data-driven. Across thousands of treated patients, publicly reported mortality rates remain low, especially when compared with other one-time, high-impact medical interventions such as organ transplantation or hematopoietic stem cell transplants.

Image credit: Alliance for Regenerative Medicine

A sector coming of age

Taken together, the signals – excuse the pun – from ARM’s 2026 update point to a sector that has come of age. Companies are learning and adapting. Investors and strategic partners are enforcing discipline while enabling growth. Regulators are modernizing frameworks to better accommodate transformative therapies. Commercial opportunities and, most importantly, patient impact, are expanding.

After four years of covering ARM’s State of the Industry for Signals, the change in tone this year was striking. The conversation has moved beyond proving that cell and gene therapy can work. Attention is now firmly on making it sustainable, scalable, and accessible to the patients who need it most.

Six-month correction of lysosomal storage disease (lysosomes are in red) using stem cell gene therapy with lentiviral IDS fused to ApoEII in neurons (green) in the brain of the MPSII (Hunter syndrome) mouse model. (Nuclei in blue). Image provided by Prof. Brian Bigger, University of Edinburgh.

Hunter syndrome is one of the mucopolysaccharidoses, a group of lysosomal storage disorders caused by specific genetic mutations and missing enzymes. In Hunter syndrome, mutations in the X-linked iduronate-2-sulfatase (IDS) lead to deficiencies in the IDS enzyme, causing the accumulation of heparan sulfate and dermatan sulfate within cells. The build-up of these sugars drives neurodegeneration, which leads to speech problems and dementia, as well as skeletal abnormalities and cardiorespiratory disease. It affects mostly males due to its X-linked inheritance.

Enzyme replacement therapy (ERT), introduced in the 1960s, is currently the only approved treatment on the market for Hunter syndrome and other lysosomal storage disorders. However, ERT has major limitations.

In an interview with me, Prof. Brian Bigger, from the University of Edinburgh, explained that “Enzyme replacement therapy works really well for many lysosomal storage disorders – as long as you’re trying to target parts of the body that are reachable by the bloodstream.” For example, bones and joints are hard to reach by the bloodstream and therefore have minimal access to the enzyme. The enzyme itself doesn’t reach the brain either due to the blood-brain barrier, which is an endothelial cell layer that excludes any large protein from the brain, preventing the therapeutic enzyme from crossing into the brain to remove toxic build-up of molecules in the neurons.

Another downside to ERT is that it must be administered for life, at a hospital, by intravenous infusion. Infusions are done weekly, each lasting 2-4 hours –  a regimen that is burdensome for patients and families. It is also costly to produce and prepare, and is therefore very expensive to administer. Idursulfase, brand name Elaprase, the ERT drug that breaks down heparan sulfate and dermatan sulfate, is the widely approved standard of treatment, but it has an annual drug cost of over CA$650,000 for a patient weighing 77 pounds.

In recognition of these limitations, Prof. Bigger and his team developed a hematopoietic stem cell (HSC) gene therapy for Hunter syndrome, now in Phase I/II clinical trials.

The clinical team, led by Dr. Simon Jones and Dr. Rob Wynn, administers G-CSF and Plerixafor to mobilize the patient’s stem cells from the bone marrow into the bloodstream, allowing the team to collect the patient’s original HSCs.

The collected HSCs are modified (transduced) using a lentiviral vector. The lentiviral vector allows for the incorporation of the correct IDS gene into the patient’s HSCs, replacing the defective gene. After quality control assessments to check for HSC viability, sterility, purity and transduction success, the patient is given Busulfan, a chemotherapy drug, to kill bone marrow cells and create space for the new, modified HSCs to engraft. Busulfan is the same chemotherapeutic used prior to a bone marrow transplant to treat someone with leukemia.

These modified HSCs, with the corrected enzyme, are returned to the patient. Once engrafted, blood cells, called monocytes, derived from these HSCs, produce and release the enzyme into the body.

However, IDS still cannot cross the blood-brain barrier (BBB) on its own.

So how do they get to the brain?

After engraftment, the modified healthy HSCs produce monocytes, which can cross the BBB. Once in the brain, the monocytes take on the same function as microglial cells and release IDS directly into the brain. Prof. Bigger notes that the correct term for these newly engrafted HSC-derived microglial cells is “peripheral-derived macrophages that are microglial-like.” Essentially, “They’re there to help clean up the brain and to act as a sort of a functional immune system within the brain,” he goes on to say.

In addition, Prof. Bigger’s team decided to construct the IDS enzyme such that it is fused to a protein tag called APOEII. This APOEII tag allows for the IDS enzyme circulating in the peripheral bloodstream to cross the BBB via receptor-mediated transport.

This dual strategy increases IDS levels in the brain far beyond what untagged gene therapy can achieve, enhancing cognitive and behavioural outcomes in the trial patients.

Prof. Bigger further explains:

“A patient who receives this stem cell gene therapy [without the APOEII attached to the IDS] will have around 20 to 200 times the normal level of enzyme in their blood circulation and only roughly one times normal enzyme levels in the brain. You’ve got a huge number of cells in your blood circulation producing enzymes for you. Which is great. But in the brain, you’ve only got the microglial cells that are producing it, and that’s why there’s so much less. So what we’re trying to do really is to drive that enzyme from the peripheral [circulation], where it’s in big excess, into the brain.”

Can you have too much of a good thing?

Pre-clinical studies show that the overexpression of IDS is not toxic. One of the reasons for this is because the IDS enzyme is only active in the acidic environment of the lysosome, which has a pH of 5. “It [higher than normal levels of the enzyme] is not going to cause a big wave of substrate degradation in the bloodstream outside of cells (the bloodstream has a pH of about 7). It all has to happen in the lysosome,” says Prof. Bigger. In addition, IDS gene expression is limited to macrophages, microglial and monocyte cells – the cells they really want to see in the brain.

However, Prof. Bigger notes that, “Too much of anything is potentially bad for you […]. So we are absolutely evaluating the effects in patients. The first patient treated, Ollie, he looks great. And he has really high levels of enzyme expression. […] I think if we were going to see any significant issues, we would have seen them by now.  But, you know, it’s a trial, so we don’t know.”

The future for adults with Hunter Syndrome

If the current trial shows positive results across all five participants, who are all under two years of age, the team hopes to expand access to older patients. The challenge is that older patients who haven’t started a brain-targeted treatment early in life have already suffered from brain degeneration, and regenerating the lost neurons cannot be done by HSC gene therapy alone.

Prof. Bigger’s team is already trying to solve that problem, too. He announced at the WORLDSymposium on Lysosomal Diseases in 2023 that his team in Edinburgh is developing an induced pluripotent stem cell-derived neural stem cell therapy with the goal of replacing neurons and rescuing lost brain function. These neural stem cells will also be engineered to overexpress the healthy gene that is missing. So far, the studies are pre-clinical, but the research team is hoping to publish their results shortly.

Our number one blog post in 2025 comes from Peach Chukwu, a medical student at the University of Nigeria. She has made the list before, and I’m not surprised this blog post was a hit. It’s not a topic we have covered previously, and clearly you were interested in learning more. Here is Menstrual stem cells and their promise. Although it didn’t make the Top 10, Peace also blogged about “menstrual stem cell implication in endometriosis,” if you missed that one.

Our second most-read blog post comes from my colleague Laine Bodnar. I’m a little surprised that so many of you are interested in learning about regulatory affairs careers, but it’s also possible you are friends and colleagues of the two women featured in the post: Zoe Anderson-Jenkins and Tracy Porter.  If you missed Laine’s helpful post, you can read it now: Regulatory affairs careers: What scientists need to know. By the way, Laine had the number one blog post in 2024, and given the topic maybe I shouldn’t be surprised about this year’s ranking. There is a loose theme happening here.

Another blogger who has made our list before – actually, he has been on it every year since he began blogging for Signals – is Kevin Robb, a scientist interested in mesenchymal stromal cells. Apparently, you are too. Coming in at number three is Mesenchymal stromal cell product joins FDA’s list of approved cell and gene therapies. If you clicked on Laine’s post from 2024 above, the theme continues.

For a complete change of pace, I’m happy to welcome Krystal Jacques to the list at number four. In her Master’s degree at the University of Toronto, she studied the embryonic origin of pancreatic stem cells. Here she writes about Freeze-thawing neural stem cells. The next blog for 2026 has been written by Krystal. Please watch for it.

At number five, we are back to a favourite blogger, as Cal Strode has been on this list before. Cal offers up a summary and his thoughts on the Alliance for Regenerative Medicine’s annual state of the industry briefing, something he has covered in the past. Here is Cal’s From innovation to international impact: ARM’s 2025 “State of the Industry Briefing” showcases maturing CGT industry.

Laya Kiani has been a blogger with us since 2024. She tackles the business and commercial factors shaping the regenerative medicine field, and her blog post Beyond cryptocurrency, how blockchain is transforming science, research and biotech funding has appealed to many of you, coming in at number six on our list. Her blog about investment patterns was number four on the 2024 list, before Laya was invited to become a regular contributor.

Some of you may know Anis Fahandej-Sadi from his popular newsletter on LinkedIn. We have been fortunate to have blogs from him a few times. His post, Lowering CAR T costs: Paths to more affordable cell therapies, is seventh on our list.

As they say, all good things must come to an end. I am happy to see Lyla El-Fayomi’s post, Regenerative Medicine News Under the Microscope – Post-Holiday Edition (December 2024, January 2025), reach number eight on the list, but sad that her time as a blogger with Signals is over. Lyla deserves a participation badge for all of her contributions since 2019! From occasional posts to wanting to contribute in a more meaningful and regular way, Lyla’s “Regenerative medicine news under the microscope” posts were thoughtful summaries and analyses of big news stories in our field, and she provided them almost monthly, until her work and academic commitments prevented that. I really appreciate her commitment to Signals and what she brought to the community. I wish Dr. El-Fayomi much success in her career and welcome the occasional blog post from her in the future, when inspiration strikes.

It’s not unusual for a blogger to be on the list in two or even three spots. This time, that honour goes to Laya Kiani for The impact of IPOs on biotech market expansion: Strategies and projections, which made the number nine spot, and Cal Strode, who takes number ten for Headwinds and tailwinds for cell and gene therapy under the second Trump administration. Congratulations to both of them.

That’s a wrap on another great year of blogging. A big thank you to these bloggers and all the others who contributed in 2025 and brought us interesting, educational and thought-provoking content. Thank you, readers, for sticking around. If you like our posts, please share them with others. We are committed to enhancing public understanding of science in Canada, and CCRM covers the expenses so we can share our posts for free.

You are invited!

If you are in the Toronto area, CCRM will be receiving an “excellence in science communications” award at a special event on January 29, 2026. CCRM, MaRS Discovery District and RCIScience will be hosting a public event entitled “Healthy skepticism: Combatting medical misinformation,” featuring a panel discussion to hear from leading communicators in science, social media and journalism. Register for the first “MaRS Mornings” of 2026 here. Molly Thomas, the host of Big [If True] on TVO, will be the moderator and confirmed panellists include Samantha Yammine, Krista Lamb and Megan Ogilvie. I hope you will join us for this worthwhile event.

via GIPHY

I’d like to wish all of you a very Merry Christmas, if you celebrate, and a Happy New Year. This year, Signals bloggers, past and present, have an additional reason to be excited. CCRM has been awarded the 2025 William Edmond Logan Award for Excellence in Science Communications from the Royal Canadian Institute for Science (RCIScience). Previous winners have included CBC’s Quirks & Quarks, Sanofi Pasteur Canada, Celestica and IBM Canada. (The award also recognizes CCRM’s podcast. Please check it out, if you haven’t already.)

If you are in the Toronto area, CCRM will be receiving the award at a special event on January 29, 2026. CCRM, MaRS Discovery District and RCIScience will be hosting a public event entitled “Healthy skepticism: Combatting medical misinformation,” featuring a panel discussion to hear from leading communicators in science, social media and journalism. Register for the first “MaRS Mornings” of 2026 here. Molly Thomas, the host of Big [If True] on TVO, will be the moderator and confirmed panellists include Samantha Yammine and Krista Lamb. I hope you will join us for this worthwhile event.

Until then, thank you to all the bloggers for their effort and dedication this year.

I leave you with this stem cell Christmas parody video to enjoy. If you are playing Whamageddon, don’t click!

Slide from Professor Tim Caulfield’s keynote at the 2025 Till & McCulloch Meetings

A recent publication on the marketing of stem cell supplements, in the International Society for Stem Cell Research’s (ISSCR) Stem Cell Reports, sparked my curiosity about these products. While I haven’t been able to find a reliable source indicating how long stem cell supplements have been around, they are being marketed to enhance stem cell function, boost regeneration and slow aging. Experts agree that these products do not contain stem cells, even though they are often sold with language that suggests stem cell–like benefits, drawing heavily on the excitement surrounding legitimate advances in regenerative medicine. As interest in longevity and wellness surges globally, so too has the commercial market built around these claims. Yet for scientists, clinicians, and informed consumers, the expansion of this industry raises critical concerns about safety, evidence and regulation.

Although stem cell supplements are a relatively young category and estimates of this product’s valuation are hard to find, the global dietary supplements market is “currently worth more than 60 billion dollars,” according to a 2024 interview with Dr. Cara Welch of the U.S. Food & Drug Administration (FDA). Some forecasts estimate that stem cell–branded supplements were valued at around US$1.2 billion in 2023, with expectations of US$2.3 billion by 2030. Other reports, depending on how broadly they classify the category, place future valuations even higher – up to US$8.5 billion by 2028. (I was unable to independently verify the original sources for these figures.) Assuming that these figures are correct, the trend is unmistakable: there is consumer demand for regenerative-themed wellness products.

Interestingly, I found a couple of stem cell clinics that cater to stem cell tourism sharing their thoughts on stem cell supplements. They agreed that scientific evidence for claims made by stem cell supplements is weak and largely unproven. Perhaps not surprisingly, these clinics recommend their own services for treating patients.

Why caution is warranted

For the lay public, the term “stem cell supplement” can easily imply that the product has regenerative powers akin to cell therapies, an assumption that is inaccurate and potentially harmful to patient decision-making. In reality, there is no robust clinical evidence that any orally ingested supplement can significantly enhance stem cell function in humans or influence disease outcomes. Timothy Caulfield, a health law and policy expert with the University of Alberta, has stated that “the storage of human stem cells in pills, liquids, or capsules is scientifically implausible” and that advertising in this category often misuses stem cell–related terminology in ways that mislead consumers.

Several risks arise from this misconception:

1. Misleading marketing may cause vulnerable patients to believe supplements can treat chronic conditions, leading them to delay evidence-based medical care.
2. Advertisements often reference “boosting circulating stem cells” or “activating endogenous regeneration.” These statements are not supported by reproducible, peer-reviewed clinical research, as stated above, and undermine public understanding of stem cell science and risk eroding trust in the field.
3. Like other dietary supplements, stem cell-branded products are subject to variable quality control. The FDA does not require manufacturers to verify purity or consistency before selling their products.
4. The frequent use of stem cell–related language in marketing can create the impression of scientific legitimacy. This can contribute to public confusion about what stem cell research actually entails, and about the difference between rigorously tested biologics and over-the-counter wellness products.

Compounding this issue is the regulatory landscape. In the United States, dietary supplements – including those marketed as stem cell-boosting – do not require pre-market approval for safety or efficacy. Manufacturers may sell products without demonstrating effectiveness, and government agencies can intervene only after safety issues emerge. This differs from Canada, where manufacturers require a product licence from Health Canada before selling supplements.

While more regulatory oversight is needed, that caution isn’t always appreciated by the public. Nevertheless, several steps could improve the situation, namely: tightening claim standards; mandating clearer labelling and quality testing; promoting public education; and encouraging the scientific community to speak openly about concerns and engage directly with the public to debunk misconceptions.

An ongoing need for public education

Professor Caulfield, the final author of the Stem Cell Reports publication, was the keynote speaker at this year’s Till & McCulloch Meetings in Ottawa, Ontario. His educational and entertaining talk about misleading health claims, titled “Twisted, Chaotic, and Misleading: Is Our Information Environment Killing Us?” touched on stem cell supplements and how the spread of misinformation “is a defining characteristic of our time.”

While stem cell supplements are expensive, and there could be biological effects as they interact with medications, etc., the harm to society is also important, as Professor Caulfield emphasized. When the public associates legitimate stem cell science with unregulated supplements, the field risks reputational damage. This matters not only for academic integrity but also for the success of clinical translation, funding and public trust.

On January 29, 2026, CCRM, MaRS Discovery District and the Royal Canadian Institute for Science (RCIScience) will be hosting a public event entitled “Healthy skepticism: Combatting medical misinformation,” featuring a panel discussion to hear from leading communicators in science, social media and journalism. Register for the first MaRS Mornings of 2026 here.  As part of the event, CCRM will be receiving the Logan Award for excellence in science communications from RCIScience. I hope you will join us for this worthwhile event.

Stem cell research holds enormous promise, but the commercial rise of stem cell supplements reflects both the excitement surrounding the field and the risks of scientific misappropriation. As the market grows, it becomes even more important for all of us to advocate for evidence-driven standards.

Ultimately, protecting the integrity of stem cell science requires vigilance, not only in the laboratory and clinic, but also in the marketplace.

Professor Paul Knoepfler, a biologist with UC Davis School of Medicine and a well-known stem cell blogger, does a fact check on stem cell supplements. Watch what he has to say on the topic below.