FDA on Stem cell therapy

The US Food and Drug Administration (FDA) has authority to regulate regenerative medicine products, including stem cell products and exosome products.

A common question that we hear is, “are stem cell treatments approved by the FDA?” The answer is that there are some treatments that are fully approved, but many are still being studied and thus don’t have complete approval yet. But there is a growing body of evidence for the benefits of these treatments emerging from around the world.

The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.

Stem cell products are regulated by FDA, and, generally, all stem cell products require FDA approval. Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.

Current therapies are not FDA approved yet. They are compliant with the rules for 361 products. What this means is that the products are not regulated as drugs. The way FDA regulates things are:

  • Medical devices – joint implants, screws/rods, DME, etc. In the world of regenerative medicine, this only applies to the kits used in PRP, bone marrow or adipose procedures.
  • Drugs – think of Lipitor, Vicodin, Viagra, etc. These are medications that have gone through a clinical trial and been approved for a specific indication.
  • Biologics – the FDA strictly regulates how biologic materials are acquired, processed, stored and used under the CFR Part 1271. Amniotic and umbilical materials fall under this category, which does not involve an Approval/Denial process like drugs do.
    • Specifically, the section under Part 1271 that applies to amniotic/umbilical tissues is Section 361 products, which are not required to be licensed or approved by the FDA and are regulated under Section 361 of the Public Health Service (PHS) Act.

Clinical trials are being conducted not only in the US but in many countries regarding the safety and effectiveness of the therapies. These studies take time to develop and it will take years before the FDA approves the use of Stem cells for different conditions.

Some other examples of approved therapies are the use of stem cells for the treatment of acute lymphoblastic leukemia, adult B-cell lymphoma and graft versus host disease in Canada. Most approved therapies use hematopoietic stem cells. Bone marrow, blood and the umbilical cord all contain hematopoietic stem cells. These cells mature into cells that make up the blood and immune system. This makes them perfect for the treatment of these types of conditions.

While stem cell therapy has not yet been approved in the US, many other countries are using them for different conditions. There are currently many ongoing studies due to the promising results that they have shown and there are different studies that indicate their tremendous promise. The type of stem cells that our clinic currently use are Umbilical Cord derived Mesenchymal Stem cells obtained from the Warthon’s jelly. These types of stem cells have been widely studied in recent years due to their advantages against other types of stem cells. The advantages include their immune-privileged status, meaning that they are not recognized as “foreign” by the immune system so don’t cause any type of rejection.

More clinical trials need to be conducted in order for an organization such as the FDA to approve the use of any type of treatment. But with promising results being seen around the world\, while we wait for the FDA to go through their process to fully approve these treatments, there’s no need to delay getting the benefits of this therapy yourself. Our clinics are delivering these therapies today, at a fraction of US prices, and just a few miles from San Diego.