McGowan Institute for Regenerative Medicine
faculty member Ira J. Fox, MD (pictured), Director of the Center for Innovative Pediatric Regenerative Therapies, a joint program of the University of Pittsburgh School of Medicine’s Department of Surgery, the McGowan Institute, and Children’s Hospital of Pittsburgh of UPMC, is co-author of the new guidelines for the responsible development of safe and effective stem cell therapies for patients. The guidelines were released by the International Society for Stem Cell Research (ISSCR), the world’s leading professional organization of stem cell researchers.
The guidelines define a roadmap for medical researchers and doctors, outlining what needs to be accomplished to move stem cells from promising research to proven treatments for patients. The new guidelines will accelerate the translation of stem cell research into practice while addressing associated scientific, clinical, regulatory, ethical, and social issues. Founded on core principles of scientific rigor and ethical conduct, the recommendations offered in the guidelines include an insistence on expert evaluation and independent oversight, a thorough informed consent process to provide patients with essential information on the unique aspects of stem cell-based treatments, and transparency in reporting of clinical trial results.
"We don't want to slow the field down," said Dr. Fox. "But we want to make sure that it is safe and careful and ethical."
"These guidelines are not novel, and I wouldn't say they're extreme," said McGowan Institute faculty member J. Peter Rubin, MD, Director of the Life After Weight Loss clinical program, Director of the Adipocyte Biology Laboratory, and Co-Director, UPMC Aesthetic Surgery Center. "These guidelines are basically the guidelines under which most human research is conducted in the United States under federal law."
Too often rogue clinics around the world exploit patients’ hopes by offering unproven stem cell therapies, typically for large sums of money and without credible scientific rationale, oversight, or patient protections. The ISSCR’s new guidelines establish standards that can be used to judge the claims made by stem cell clinics and whether the treatments they offer are being developed responsibly. The ISSCR also offers a handbook for patients and their doctors evaluating a stem cell therapy.
Almost every day, McGowan Institute faculty member Burhan Gharaibeh, PhD, research assistant professor within the Stem Cell Research Center, part of the Department of Orthopedic Surgery at the University of Pittsburgh, fields calls from people hopeful about stem cell treatments they've read about on the Internet.
"Unfortunately ... they have this misconception that there is a solution to this particular problem that they have," said Dr. Gharaibeh. "Often I have to stop them and say, 'Listen, that just isn't the case.' "
He tells them they need to make sure they enroll in clinical trials that have federal oversight, and are transparent with the risks and results of treatment. In general, trials offered in the United States and Western Europe fit that criteria, he said.
The ISSCR urges governments and regulatory bodies to enact the recommendations outlined in these guidelines. The guidelines call for countries without an official regulatory body to develop a way to monitor new stem cell-based treatments, and the ISSCR has offered to advise agencies that want to build these regulatory capacities.
“You can't make people do what they don't want to do," Dr. Fox said. "We all know that there are business advantages, and when you get stem cell tourism, it brings money into the country.”
“But international pressure can do a lot to sway a government,” he said. “And for the scientists at these clinics, we can say to them, 'If, in fact, you are performing such studies and you're not following the guidelines, then we're not going to invite you to our meeting to present your data.'”
To develop these new guidelines, the ISSCR convened an international task force of experts in stem cell science, clinical research, and bioethics from 13 countries. The task force was led by Dr. Olle Lindvall, co-chair of the ISSCR task force that developed the guidelines and professor in clinical neurology at the University of Lund, and Dr. Insoo Hyun, ISSCR member and associate professor of bioethics at the Case Western Reserve University School of Medicine.
Illustration: McGowan Institute for Regenerative Medicine.
International Society for Stem Cell Research and Cell Press News Release (12/03/08)
Market Watch (12/03/08)
Pittsburgh Tribune-Review (12/04/08)
International Society for Stem Cell Research
Information links for the Guidelines for the Clinical Translation of Stem Cells
Bio: Dr. Ira Fox
Bio: Dr. Peter Rubin
Bio: Dr. Burhan Gharaibeh
Abstract (Cell Stem Cell, Volume 3, Issue 6, 607-609, 4 December 2008)