Turning Body Parts into Drugs: Geron ceases Stem Cell Approval citing Regulatory Costs

turning body parts into drugs

Wow, what a bombshell this morning. Geron was one of the big dogs in the stem cell business world, most recently in the news for the first FDA approved spinal cord injury study. Yet the company just pulled all funding out of pursuing U.S. FDA approval for stem cells citing the excessive costs of the research required by U.S. FDA to turn it’s stem cells into an approved drug. With biotechnology funding down in stem cells due to regulatory hurdles, this Geron announcement is a huge problem for the regulatory status quo. It means that many companies are likely to follow by either moving their technologies out of the U.S. for approval or pulling the plug on their US FDA research. This “brain drain” is leading more companies overseas where regulation makes more common sense. What’s needed? A new model that balances safety and efficacy concerns rationally and that moves stem cells from the “drug approval” approach pushed by U.S. FDA to the registry approach being pushed by physicians. A registry approach is one where patients are treated in a safe and controlled manner using a new technology and all data is collected for later review. An Institutional Review Board decides what’s safe enough to allow testing and the results are published with patients and doctors making up their minds about risks and benefits. In addition, while the FDA has pushed chemical drug concepts like “Purity and Potency” onto cell therapies, the registry approach would recognize that these cells are body parts and as a result, are only as good as the tissue from which they originate. The upshot? Turning body parts into drugs is at best fitting a square peg into a round hole and at worst a recipe for the financial disaster (one that’s being played out right now). There is no benefit to society to take the cells in our bodies and pretend they are the same as chemical drugs-period.

Learn More About Regenexx® Procedures
Request a digital booklet and more information to learn about alternatives to orthopedic surgery and the Regenexx patient experience.
We do not sell, or share your information to third party vendors. By submitting the form you agree that you've read and consent to our Privacy Policy.
Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

If you have questions or comments about this blog post, please email us at [email protected]

NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

TO TOP