Safety assessment of adipose-derived stem cell product for clinical trials

by Alexey Bersenev on August 29, 2011 · 1 comment

in adipose, cell product, clinical lab, mesenchymal

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I wrote before about some preclinical safety assays for human adipose-derived mesenchymal stem cells (AMSC). Few days ago I came across of very nice study, assessing safety of AMSC after intravenous administration in mice and human. The list of assays, performed by investigators before clinical trial, is impressive. Magically, this study is available in open access.

First of all, I’d like to quote the editorial, which highlights the significance:

Although several previous studies have evaluated the oncogenic potential of implanted hAdMSCs (e.g., [4–9]), the article by Ra et al. is among the first articles to provide a detailed report of the data required to fulfill regulatory approval for an hAdMSC IND and Phase I safety study [1]. This represents an important milestone in the maturing field of cell therapeutics. It documents the steps taken by biotech and academic investigators to insure that their clinical stem cell research will be conducted with the same rigor that has been used historically to oversee the development of traditional pharmaceuticals.

The authors performed the following series of assays: identity (immunophenotype by flow cytometry, differentiation capability by immunohistochemistry), gemone stability (karyotyping and single-nucleotide polymorphism), stability, toxicity, sterility, tumorigenicity. I encourage you to read this study especially for tumorigenicity in vivo assays.

With the evidence accrued through these analyses, the investigators progressed to a Phase I safety study in 8 male spinal cord injury patients under an Investigational New Drug (IND) application approved by the Korean Food and Drug Administration and a protocol approved by their hospital Institutional Review Board.

The only thing which puzzles me is the absence of potency assay. In other words – the rational behind of use AMSC in spinal cord injury. What do you think?

{ 1 comment… read it below or add one }

Jeanne Adiwinata Pawitan May 18, 2014 at 7:01 am

Dear Alexey,

Thanks for the information. I tried to take the article from the Publisher (Mary An Liebert), but it is not free. Because you said that it is open access, I tried googling the title, and I got it.

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