This year is very interesting for RegenMed and cell therapy industry. There were a number of notable market approvals, including stem cell, gene and tissue engineered products. In order to keep track of these approvals, I’m going to summarize it today. I’ll focus on therapeutic products and devices.
The year started from 2 remarkable approvals of new “stem cell drugs” by Korean FDA:
Cartistem (Medipost) – allogeneic umbilical cord-derived mesenchymal stromal cells for degenerative arthritis.
Cupistem (Anterogen) – autologous adipose tissue-derived mesenchymal stromal cells for anal fistula (Chron’s disease).
Both products considered as “stem cell drugs” and will be available on Korean market.
Cell-based tissue engineered product approved by US FDA:
Gintuit (Organogenesis) – allogeneic cultured keratinocytes and fibroblasts (derived from neonatal foreskin) in bovine collagen to treat oral mucogingival conditions in adults. Read FDA notice and Organogenesis press-release. Gintuit became the first tissue engineered product approved by FDA- CBER via BLA (Biologics License Application).
US manufactured “stem cell drug” approved in Canada and New Zealand:
Prochymal (Osiris) – allogeneic bone marrow-derived mesenchymal stromal cells for acute pediatric GVHD (Graft-versus-Host Disease). Read press-releases about approval in Canada and New Zealand. Osiris is seeking market opportunities for Prochymal in other countries. The company has a “hard time” with FDA, but seem like Prochymal still under review by US agency.
First gene therapy product approved in Europe:
Glybera (UniQure) – lipoprotein lipase gene for inherited deficiency. It was the first ever approval of gene therapy product in Europe and the first experience for EMA. Read press-release.
Two more cord blood product licensed by US FDA:
More than a year ago FDA mandates US-based cord blood banks to license their products via BLA. The first product was approved last year. This year we got 2 more approvals:
Cord blood product of Clinimmune Labs, University of Colorado Cord Blood Bank
Ducord (Duke University, Carolinas Cord Blood Bank).
So, US cord blood banks are moving to that direction. More approvals will come next year.
Angel (Cytomedix) – Platelet Rich Plasma (cPRP) system. Approved by US FDA as 501(k) device.
SmartPReP 2 BMAC (Harvest-Terumo) – point-of-care bone marrow processor for concentration of mononuclear cells in “no option” critical limb ischemia indication. CE Mark granted by BSI for sales in Europe.
That’s all notable approvals on the market in 2012. Please let me know if I missed something important.