ISSCR releases new guidelines for moving stem cells from bench to bedside

[Wise Young]

http://interestalert.com/story/06120000aaa00b41.nw/siteia/HELTHSCI/health/science.html

At the sixth annual meeting of the International Society for Stem Cell Research, a task force of leaders in the field announced a draft set of guidelines to ensure that rigorous best practices are applied to the clinical translation of stem cell research from the laboratory to human subjects. The guidelines are the culmination of months of discussion by scientists, ethicists, public policymakers, clinicians, industry representatives and members of the public from 13 countries. (The full guidelines will be posted at www.isscr.org.)

"These guidelines are critically important to the future success of the field," according to Dr. George Q. Daley, ISSCR president and associate director of the Stem Cell Program at Children's Hospital Boston. "Not only does the use of untested therapies put patients at risk, it jeopardizes the legitimate practice of all translational stem cell research."

In strongly worded language, the guidelines "condemn" the use of stem cell therapies outside of an established clinical trial, particularly when patients are charged for "advertised medical services that constitute experimental, unproven and unestablished interventions." The guidelines call upon regulators in countries where these putative therapies are offered to regulate such practices to prevent exploitation of vulnerable patients. The guidelines call upon scientists and clinicians to conduct research with transparency and adherence to rigorous independent scientific and ethical review.

The guidelines address three major areas of the clinical translational process involving all types of human stem cells and their direct derivatives, including cell processing and manufacturing; pre-clinical studies; and clinical research. The guidelines also make specific recommendations for ethical oversight, peer review of studies, informed consent and protection of subjects, avoidance of conflict of interest, clinical trial design and reporting, and long-term follow up of patients. Also addressed are issues of social justice, such as public engagement in policy making and fair access to treatment, in particular, offering affordable treatments to patients in resource-poor countries.

The guidelines do allow for treating a specific patient or small numbers of patients outside of a clinical trial in "exceptional circumstances of justified medical need" where reasonable scientific evidence exists that the patient or patients might benefit and not be harmed. All clinical trial regulations related to informed consent, clinical follow-up, independent expert review and institutional support and accountability still apply.

Following a solicitation of comment period from June 12 to Sept. 15, 2008, the task force will develop a final version of the guidelines, expected to be released by the end of the year. At that time, the ISSCR will release an advisory for patients considering stem cell therapy to help guide them in evaluating programs and treatments. The advisory will be posted on the ISSCR Web site, www.isscr.org.

[Wise Young]

Reporters have been calling me about these guidelines, particularly whether or not it would affect medical tourism abroad.

I told the reporters:

1. I support these guidelines. They are essential what GCP (Good Clinical Practice) guidelines recommend for all experimental therapies. It is important to do clinical trials, to get appropriate institutional review and informed consent, and document the results.

2. I doubt that guideline will affect "medical tourism", i.e. patients going overseas and paying for experimental therapies. It is likely to have little effect since neither the patients nor the doctors who are proving the therapies pay much attention to these kinds of guidelines.

3. The real issue is who decides when a therapy is safe and effective. Many of the people overseas who are offering therapies are convinced that their therapies are working for patients. They don't regard the therapy as experimental.

4. Regulatory agencies also have not developed rules concerning cell transplant. Most agencies do not regulate autografts (grafts from one part of the body to another) and minimally manipulated cell transplants (such as blood). Some countries have already approved fetal cell transplants for certain conditions and use of fetal cells for spinal cord injury is being done under the pretext that this is off-label use.

5. The organizations that are most likely to observed and respect these guidelines will be researchers and universities. It is possible that regulatory agencies may adopt these guidelines and enforce them. When that happens, they will have great influence.

Wise.

[NoDecafPlz]

Thanks Doc.