The Three Steps So Far, Transparency Initiative at the FDA
May 20th, 2010
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Through its transparency initiative, the FDA has considered a wide range of options for increasing transparency about these and other aspects of its work. The task force (that includes senior leaders at the agency) believes that implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products. Read more…
Categories: Food and Drug Administration (FDA), Healthcare
Osiris Therapeutics is a stem cell therapeutic company focused on developing products in the inflammatory, orthopedic and cardiovascular areas. OSIR’s Q4/09 results reported achievement and data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage GvHD with significant improvement in response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD – the two most deadly and difficult-to-treat forms of the disease. Graft-versus-host disease (GvHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack.
The objective of the filed IND Application is to start a Phase I/II study at multiple centers. The study would involve the use of retinal cells, which have been developed from the stem cells of the embryo for the treatment of patients suffering Stargardt’s Macular Dystrophy (SMD).
Bioheart (BHRT.OB) is a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic, acute heart damage, and peripheral vascular disease. BHRT.OB initiated its REGEN trial, a Ph I clinical trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). 
ISCO.OB is focused on using hpSC to treat severe diseases of the eye, the nervous system and the liver where cell therapy has been proven … clinically … yet is limited by the availability of safe immune-matched human cells. ISCO.OB is about to demonstrate the therapeutic applicability and potential immune rejection advantages of hpSC lines relative to other stem cell classes. 
Stem cell surgery options and procedures continue to evolve at a rapid rate and companies such as Cytori Therapeutics are making preparations to serve more medical centers and cosmetic surgery facilities with stem cell orders in the oncoming years. Most recently, Cytori has received an order for a StemSource Cell Bank from Cosmetic Surgery Seishin in Japan. 
Results from Cytori Therapeutics’ preclinical fat grafting study have been published in the February issue of the Annals of Plastic Surgery. This article, entitled “Supplementation of Fat Grafts with Adipose-Derived Regenerative Cells (ADRCs) Improves Long-Term Graft Retention,” examines the science behind cell-enriched autologous fat grafting and its application to cosmetic and reconstructive surgery.