Genomic stability of clinical-grade mesenchymal stromal cells – a proposal for international initiative

by Alexey Bersenev on January 5, 2012 · 1 comment

in cell product, mesenchymal

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The discussion about genomic stability of mesenchymal stromal cells (MSC) is still continuing. We wrote about the importance of this here and here. In today’s issue of Cell Stem Cell journal there are two commentaries to Ben-David’s article about this issue. The one says – no, the problem is overblown, the other says – yes, the problem is here.

The authors made a good arguments from both sides. It seems to me that both sides agree on monitoring genomic stability in propagated MSC products manufacturing.

I’d like to add some thoughts. First, I’d like to note that the official position of International Society for Cellular Therapy (ISCT) was not cited. Second, until now, there is no recommendations on genomic stability assays as release criteria for MSC-based clinical products. Third, if we don’t have enough data to recommend assays for cell product developers, we should make an effort for international initiative. Analogously to global collaboration project “International Stem Cell Initiative“, Ben-David proposed the same thing for MSC community:

We believe that the MSC field would benefit from a similar large-scale prospective analysis…

I like this approach. I think, professionals may think of the following steps:

  1. Propose the idea to international community and discuss the necessity of global collaboration project (It could be done on upcoming ISCT annual meeting);
  2. If initiative will get approval by professionals, set up a survey (analogously to International Stem Cell Initiative) and designee participants and responsibilities;
  3. In survey include only authorized GMP-grade facilities manufacturing MSC for regulated clinical trials and ask: cell identity, number of passages, genomic stability by defined assays and so on;
  4. Collect, analyze data, make a conclusion and give recommendations – yes, problem is important and we this and this assays should be performed or no, there is no problem with it and no additional assays required.

What do you think?

{ 1 comment… read it below or add one }

Bourin January 23, 2012 at 4:41 am

I totally agree with you. This international initiative should be the best answer to the problem and may also help regulatory authorities in their decisions.


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