Regenerative Medicine Guru

FDA issues Complete Response Letter to Fibrocell Science BLA

Darin — Sun, 27 Dec 2009 09:15:54 +0000

In follow up to an earlier post on Fibrocell Science, Inc., according to the company on 21-December the FDA issued a ‘complete response’ letter that identifies the need to provide histopathology biopsy data on patients treated with the autologous fibroblast product as well as to resolve some manufacturing issues (CMC). The details of the letter [...] No related posts.

Will Fibrocell Sciences be the 1st Regenerative Medicine Product Approved by the FDA in over 12 Years?

Darin — Mon, 02 Nov 2009 03:24:35 +0000

I had a chance to attend part of the October 09, 2009 FDA Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss the biologic license application (BLA) for Fibrocell Science’s autologous fibroblast product intended to treat nasolabial fold wrinkles. Don’t be surprised if you have never heard of Fibrocell Science, Inc. Prior to filling [...] No related posts.

ChondroCelect is First Advanced Therapy Medicinal Product Approved in EU

Darin — Thu, 29 Oct 2009 21:46:40 +0000

For those following the commercialization of regenerative medicine products, there has been some promising news this month. Tigenix, based in Belgium, received authorization on October 09, 2009 from the European Commission to market ChondroCelect, its autologous chondrocyte implantation (ACI) product. This is the first medicinal product to be approved as an Advanced Therapy Medicinal Product [...] No related posts.

Human Tissues: Never Trust, Always Verify

Darin — Tue, 27 Oct 2009 23:54:18 +0000

On October 13, 2009, the FDA posted on its website a news release from the U.S. Attorney concerning a California man who on multiple occasions falsified records related to the suitability of human tissues for clinical use. This is unfortunately just one example of problems with those supplying human tissues. Follow this link to the [...] No related posts.

New FDA Proposed Rule will Impact Regenerative Medicine Products

Darin — Fri, 02 Oct 2009 00:30:16 +0000

For those involved in creating regenerative medicine products that combine cells with various biomaterials, such as natural or synthetic scaffolds, you should be aware that the FDA recently issued a new Proposed Rule for these types of medical products. In regulatory speak these are “combination products” since each component can be regulated separately. For example, [...] No related posts.

IXA Statement on Xenotransplants for Type 1 Diabetes

Darin — Fri, 07 Aug 2009 15:48:15 +0000

For those of you following developments in the field of xenotransplantation, the International Xenotransplantation Association (IXA) has recently developed a proposed Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes. In my quick read of the statement it appears to be a comprehensive, well thought out document that [...] No related posts.

Stem Book – An Excellent Information Resource

Darin — Thu, 02 Jul 2009 14:31:05 +0000

For anyone looking for a credible source of information on stem cell biology, I highly recommend checking out StemBook from the Harvard Stem Cell Institute. As is states on it’s website: Stem Book is an open access collection of invited, original, peer-reviewed chapters covering a range of topics related to stem cell biology written by [...] No related posts.

Cautionary Tale: Tumors Caused by Neural Stem Cells

Darin — Thu, 19 Feb 2009 15:49:35 +0000

I usually avoid commenting on current events occurring in the field of regenerative medicine, primarily because I can’t keep up! In this case, I believe the recent publication by Amariglio et al, has FDA regulatory implications for the clinical development of therapies based on stem cells. The under-lined portion of the title of the publication [...] No related posts.

My 2008 Presentations & Articles Relevant to Regenerative Medicine

Darin — Sun, 28 Dec 2008 21:49:56 +0000

2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the ‘better late than never” category, I thought I would share some of [...] No related posts.

13 Tips for Successful FDA Meetings

Darin — Mon, 21 Jan 2008 20:30:00 +0000

There are many reasons for meeting with the FDA during development of a regenerative medicine product. Some regenerative medicine products are more novel than others, meaning they are so unique they have never been studied in human clinical trials. Others may not be first of its kind, but may be used in novel clinical applications [...] No related posts.