The FDA’s letter raised questions in connection with Parcell Laboratories’s position that the PureGen product is within the classification of human cell, tissue, and cellular or tissue-based products regulated solely under FDA’s regulation.
Parcell Laboratories has responded to the FDA’s letter on 21 July 2011 with more complete information of the function of PureGen and how the product meets all of the criteria for being marketed under FDA’s regulation.
Dirk Kuyper, Alphatec Spine’s president and CEO, stated, “Both Alphatec Spine and Parcell Laboratories are fully committed to work closely and collaboratively with the FDA to address the questions related to the PureGen product. We look forward to discussing the PureGen product with the FDA and sharing our clinical outcomes to date.”
About PureGen osteoprogenitor cell allograft
PureGen is a highly concentrated, pure population of adult stem cells that originates in bone marrow and is collected from live, healthy donors for optimal cell functionality. Unlike stem cell products that are currently commercially available, which have an unknown population of mesenchymal stem cells (MSCs) and are harvested from cadaveric donor tissue, PureGen delivers a similar potency of a pure adult MSCs without the need for cultural expansion.
The PureGen osteoprogenitor cell allograft was launched in October 2010 and has been successfully implanted in over 500 patients with no reported adverse events, complications or complaints. The product is used primarily in spinal fusion procedures for both cervical and lumbar spine. There are three controlled prospective studies currently underway to further establish the performance of the product by both academic and community-based spine surgeons.
To read FDA’s untitled letter please click here.