Update on Cell Surgical Network IRB Status

Cell Surgical Network
Cell Surgical Network.

The Cell Surgical Network is a for-profit network of clinics offering various stem cell-related interventions, which began with the California Stem Cell Treatment Center.

I have interviewed Drs. Elliot Lander and Mark Berman of the Network in past (Part 1, Part 2) and I raised some concerns about the network in a follow up Part 3 post, which was replied to in a lengthy comment by Dr. Berman. In the course of this dialogue it was indicated that Cell Surgical Network had an IRB through the International Cellular Medicine Society (ICMS).

The point of today’s blog post is to provide an update on the IRB situation.

Cell Surgical Network has informed me that the ICMS IRB has been cancelled. Uh oh.

Drs. Berman and Lander now have some IRBs through a different organization, the International Cell Surgical Society (ICSS).

Update: California Stem Cell Treatment Center and the two doctors are battling the FDA in court as of 2020 in a much-watched case. DOJ even cited this blog The Niche in the lawsuit. The government had sought summary judgment but didn’t get it. See the law firm Venable’s take on this development here.

1 thought on “Update on Cell Surgical Network IRB Status”

  1. David T Harris, PhD

    IRB approval or not, it still does not address the issue of FDA’s requirement for an IND or BLA application. IRB approval does not satisfy the FDA in this regard as most samples are more than minimally manipulated regardless of whether autologous in nature or not..

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