In the past many of us have wished there was a list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me, but I couldnt find a list.

As a result, the generic answer was, the FDA has approved umbilical cord blood therapies for cancer or immune disorders. Also, bone marrow transplantation, while not formally approved, is essentially an approved therapy.

Today we have more information and the goal of this post is to fill you in on where things stand.

Its encouraging.

FDA and cell therapies | List of diseases treated by stem cells | Key Context | Cell & Gene Therapies | List of FDA approved therapies 2022 | FDA approved stem cell clinics?| References

Other than what I mentioned above, there was nothing else approved that was an actual stem cell therapy. There were, however, cellular therapies approved even if not related to stem cells. In a way these fit into the broader category of regenerative medicine.

Note that you can watch me discuss this post in a new YouTube Video below.

What about today in 2022? Before we get to the approved products, I made a short list of the diseasestreated by stem cells.

Note that only very specific products matched with specific forms of these diseases have the FDA OK. For instance just because damaged cartilage is on the list doesnt mean anything goes. Theres no approval to treat it with fat stem cells, bone marrow, umbilical cord cells or exosomes.

The list of diseases has been growing. What about the products?

We need to turn to the FDA itself for the clearest answer on where things stand now.

Too often stem cell clinics claim that what they offer is FDA approved. In actuality at best what some of them sell is not FDA approved, but rather technically compliant with the rules for 361 products. What this means in English is that the products are not regulated as drugs.

So what does the FDA have to say about what they have approved?

In mid-2020, they issued an advisory, Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. In it they wrote:

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.

This fits with the general boilerplate some of us in the stem cell field have used, as noted earlier.

Note that, of course, the US and the FDA are not the only ones in this arena. The Alliance for Regenerative Medicine has what we might call an international list of cleared cell and gene therapies here.They are a great organization.

The good news today is that the agency has an actual list that is publicly available. Even better news is that there are more approved cell therapies than last time I tried to tackle this topic.

An interesting side note is that the agency for several years now has been combining together cell and gene therapies into one category. This is also reflected in their Regenerative Medicine Advanced Therapy (RMAT) designation program, which contains both types. RMATs still have to go through the trial approval process but get special consideration. You can see a help infographic below that my intern Mina made of the clinical trial approval process.

The formal FDA list of approved drugs made from stem cells is called, appropriately enough, Approved Cellular and Gene Therapy Products.

The current list is up to date as of September 1, 2022. Im going to update this post as the agency updates their list. Its interesting to speculate on how different this list might be in as short as 5 years given the exciting clinical trials that are ongoing now. In 10 years I predict its going to be a much longer list.

What about list of FDA approved stem cell clinics?

Such a list doesnt exist.

Why?

The reason is because no clinics have FDA approval. While some clinics sell stem cells that dont need formal FDA drug approval, most need that approval and yet dont have it.

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List of FDA Approved Stem Cell Therapies & Drugs - The Niche