FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it.

The agency has been busy in the past couple of years but hasn’t done as much as some of us thought it would about stem cell clinics recently. Is there a pattern of action on birth-related cell producers for clinics?

FDA focus on clinic-related umbilical cord cell drug makers

The agency warned an Idaho company that produces and sells umbilical cord cells. The firm, Smart Surgical, has been doing business as Burst Biologics.See FDA warning to umbilical cord stem cell firm. The warning letter noted that the products are drugs because they do not qualify for the 361 exemption. A number of manufacturing issues were also noted. From Burst’s Linkedin page they say, “Tissue products offered by Burst have three main composition components: umbilical cord blood (UCB), cancellous bone, and amniotic tissue.”

While more broadly the FDA has done surprisingly little on stem cell clinics since their own enforcement discretion period ended last May, a pattern seems to be emerging of warnings and other actions targeting birth-related cell manufacturers.

In addition to the new warning letter to Smart Surgical, recent steps by the agency include warnings to Liveyon, Predictive Biotech, and Utah Cord Bank.

At some point will clinics have a harder time getting umbilical cord and other birth-related materials to sell?

As to the ubiquitous adipose stem cell clinic industry, which often is not even really selling interventions that are mostly true adipose stem cells, it seems the FDA may be still waiting on the verdict on the almost never-ending federal district case here in California before it does anything major.

In the mean time, people are still going to such clinics so I believe the waiting by the FDA (if that’s indeed what is happening) has risks and costs to the public.

Moonshot rejuvenation & cell therapies for cancer

Check out FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments. This seems to be a revival of Biden’s previous Cancer Moonshot when he was VP.

This moonshot announcement also resonated with this good news that the FDA approves cilta-cel for multiple myelomafrom Medical News Today

This CAR-T product is also known as Carvykti. It was initial studied in China and then given priority review status by the FDA here in the U.S.

FDA draft guidances

Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry

Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry

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