Stem Cell Research: Recent Legal Decisions and Unauthorized Treatments

On August 23, national media began focusing much attention on embryonic stem cells, because a judge from the U.S. District Court in Washington, D.C. issued a preliminary injunction banning federal funding for virtually all embryonic stem cell research.

As a result of these legal developments, media has also been placing attention on “stem cell tourism,” the promotion of unapproved stem cell treatments (embryonic and otherwise), mostly outside the U.S.,  for a wide range of conditions including retinal degenerative diseases. Virtually all of these treatments have not been evaluated in clinical trials authorized by the FDA or other foreign oversight organization with rigorous standards. Experts estimate that there may as many as 700 businesses offering these so-called treatments, which can cost tens of thousands of dollars. These companies have no peer-reviewed, published data supporting their claims of treatment success.

If you are affected by a retinal disease or other condition for which stem cells are being proposed as a treatment, we at the Foundation strongly advise you not to seek these so-called treatments, because they have not been rigorously studied. Most of these treatments are available in locales where legal safeguards are often not in place to protect the patient.

Treatments that have not been approved by the FDA or other regulatory authority are risky. Both the safety and effectiveness of these therapies have not been adequately or objectively evaluated. The likelihood of complications and detrimental outcomes is potentially high.

The Foundation Fighting Blindness funds the world’s top retinal researchers including those that are making great in advancements in the development of stem cell therapies. We hope federally funded embryonic stem cell research will be allowed to continue. Regardless of forthcoming legal decisions or legislation on federal funding, the Foundation will continue to invest in stem cell research, including projects that involve embryonic stem cells.

For more information, read the article, “Health experts warn of “stem cell tourism” dangers,” and stay tuned to www.FightBlindness.org for more updates from the Foundation on both legal and research-related developments on stem cell research.

By Stephen Rose, Ph.D., Chief Research Officer, Foundation Fighting Blindness