September 30, 2020

The Niche

Knoepfler lab stem cell blog

Recommendations to ICMS for improved practices

Yesterday I posted an interesting interview with ICMS President Dr. Ricardo Rodriguez. I again thank Rodriguez for participating. Please note that one issue that I had already raised to Dr. Rodriguez was that I could not find the membership of their IRB listed on their website and this was apparently just addressed as that information can now be found here.

Based on his answers, reader responses, and discussions I have had, here are my recommendations to ICMS to improve their operations toward our shared goal of innovative, safe and effective cellular therapies. A big hat tip to my blog readers, especially Alexey.

1) Include on the homepage of your website an easy to find patient page of resources, rights, and educational materials. In my opinion this is essential. An integral part of cellular medicine is of course the patients. However, your website gives the impression that your primary concern is the rights of doctors. For example, your website says (emphasis mine) of ICMS “No other group has done more to protect a physician’s right to practice stem cell and regenerative medicine.” What about protecting patients? That has to be articulated on your website on the home page and part of that is education of patients in terms of their rights and to improve their knowledge of the science. Part of your mission statement, in fact the very first line of it says “To provide education, oversight and best practices to assure patient safety, ethical conduct and effective treatment”. Put this into action.

2) Establish an external advisory board. There is a perception, fair or unfair, in the stem cell field about potential conflicts of interest between the ICMS leadership (whether board members or not) and the ICMS IRB. Your written policy that ICMS board members cannot serve on the IRB is clearly important. More broadly to address the issue of conflicts of interest, I would recommend that the ICMS establish an external advisory board of leaders in the cellular medicine field who are not members of ICMS. The board’s recommendations and advice can remain confidential (or not), but may prove instrumental in the continuing evolution of ICMS and in avoiding even the appearance of conflicts of interest. List the members of this board on your website.

3) Work toward an improved relationship with the FDA. Generalizations such as that the FDA views all stem cell products as “drugs” are not helpful and only serve to promote an adversarial relationship.

4). Improve transparency. Make it easy for visitors to your website to find a list of the clinics you are evaluating and provide more information on the patient registry.  Include a history of who were previous board members and who were previous IRB members. Provide a more in depth description of the accreditation process and standards. Provide a detailed policy on manufacturing standards (GMP, GTP, etc). Include on your website a public ICMS member directory.

5) Promote rigorous clinical trials.  Also, define the minimum standards for such trials on your website.

6) Incentivize publication by ICMS members in peer-reviewed journals of data that is non-anecdotal (i.e. not n=1). 

7) Establish working relationships with other professional stem cell organizations. I believe it is important for ICMS to be more integrated into the world of stem cell organizations, including organizations that are more diverse and not strictly adult stem cell clinical organizations (e.g. ISSCR). Yes, some of these organizations may not share your vision on specific issues, but I believe your future depends on interaction. The collaboration with AABB seems like a step in the right direction in this regard.