La Jolla, Calif.-based StemGenex commented on the FDA's plans to regulate adult adipose-derived stem cells treatments.
Here are five insights:
1. The company encourages collaboration between the FDA and accrediting organizations to pave a regulatory path for stem cell treatments.
2. Currently, the FDA guidance on human cells, tissues or cellular or tissue-based products, reads that adipose-derived stem cells from a patient should be regulated in the same vein as a manufactured drug.
3. The drug approval process could take as long as 15 years however, so some argue this would greatly bar patients from accessing stem cell therapies in the United States.
4. Therefore, StemGenex recommends adult adipose-derived stem cell therapies should be regulated by standards similar to the American Association of Blood Banks. The AABB standards are built on quality, scientific research and patient safety.
5. StemGenex additionally proposes stem cell treatment providers register in a national directory.