International Committee Recommends Stringent Guidelines for Translating Stem Cell Therapies From the Lab Bench to t... (gulators in countries where these putati...)

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International Committee Recommends Stringent Guidelines for Translating Stem Cell Therapies From the Lab Bench to the Bedside

Date:6/12/2008

gulators 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, http://www.isscr.org.

The guideline's task force was chaired by Dr. Olle Lindvall and co-chaired by Dr.
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