FDA needs to quickly act against IRBs enabling risky fat stem cell clinics

alphabet soup stem cell acronyms
Alphabet soup of stem cell acronyms; IRB needs to be added to future version of photo!

Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that.

alphabet soup stem cell acronyms
Alphabet soup of stem cell acronyms; IRB needs to be added to future version of photo!

Why would specific IRBs approve for-profit “experiments” by stem cell clinics using unproven fat stem cell injections, which are now clearly defined by the FDA as unapproved drug products being marketed unlawfully by clinics?

First, let’s ask and answer: what’s the purpose of an IRB? It’s a common acronym (shoot, I didn’t include it in my alphabet soup stem cell acronym photo from many years back), but what does it mean really?

According to the FDA, here’s what IRBs are all about (emphasis mine):

“Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.”

There’s that major emphasis there on protecting research participants, which in the case of stem cell clinics means their customers. Unfortunately, the specific IRBs approving what stem cell clinics are doing seem more focused on protecting the stem cell clinics, which to me directly goes against the mission of IRBs more generally.

The FDA oversees IRBs and can warn or even shut them down. About a half-dozen years ago, the FDA warned both the Texas stem cell clinic Celltex and its IRB, but strangely the FDA has been quiet in regard to stem cell clinic IRBs ever since. I don’t know why. (Note that while IRBs need to be approved by the FDA, that doesn’t mean that when such an IRB in turn approves a specific kind of research that the research has FDA approval or clearance.)

Again, why do some IRBs seem happy to approve unlawful marketing of fat stem cells? The most likely explanations to me are (1) the IRBs often have members who are themselves either stem cell clinic operators or their advocates so naturally they might tend to approve each other’s stuff, and perhaps less likely but in play in some cases (2) there’s some financial angle to this.

If a particular IRB approves the for-profit experimentation by a stem cell clinic using an unapproved drug product like fat stem cells, the FDA needs to do something about it. The agency should send them a warning letter.

I call on the FDA to take action on stem cell clinic IRBs that have been approving widespread, potentially unlawful use of unapproved stem cell drug products on patients.

3 Comments

  1. Any IRB at this point in the game that does not understand that adipose-derived cell experiments do not meet FDA guidance for either homologous use or minimally manipulated should be shut down.

  2. One point on IRCB rules – The FDA requires IRBs to register online, but does not review the registrations in advance or consider them to indicate compliance. Similar in some ways to the “honor system” used at clinicaltrials.gov

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