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Informed consent standard for stem cell-based interventions released by ISSCR

The International Society for Stem Cell Research (ISSCR) has released new informed consent standards for stem cell-based interventions performed outside of clinical trials.

Aug 14, 2019
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5 Comments

How about posting the consent form?  It doesn't seem to be available yet at the ISSCR website?

RegMedNet 30 days ago

Hi James - we'll update this post with a link to the form as soon as it's available!

Jack Mosher 30 days ago

the link is currently available through a news item on isscr.org.  The link is:

http://www.isscr.org/docs/default-source/policy-documents/isscr-informed-consent-standards-for-stem-cell-based-interventions.pdf.

We are working on updating the website so that this document has its own page in our "Professional Resources" section.

RegMedNet 30 days ago

Hi Jack - thanks so much for sharing the link, we have included the link in the article!

Mr. Mosher, thanks for sharing the link!  Other seemingly obvious paths were not proving productive.  Given the importance, a button on the ISSCR homepage would be a good idea.

Now that the ISSCR is understandably not endorsing non-approved stem cell treatments, but supporting interested patients with excellent information to help them make better treatment decisions in the current stem cell medicine environment, it would be great if the organization would take on the challenge of helping treating physicians to document their stem cell medical practice experience in a manner that could better informs the safety and efficacy of this growing new medical discipline.

Call it "physician stem cell clinical science," if you will.  With now informed patient consent,  documenting treatment methods,  documenting treatment course, documenting treatment outcomes, and sharing the data for statistical analyses in a well curated public database could be an important complement to the more patient-limited FDA-authorized stem cell clinical trials.

And I must add, whether private clinic treatments or authorized clinical trials, specific stem cell dose must be known for sounder interpretation of all treatment outcomes.  Too bad the ISSCR's new consent standard does not address the importance of requesting objective data on how many stem cells patients will receive, if in fact any at all.

James L. Sherley, M.D., Ph.D.

Asymmetrex