The stem cell industry has seen little regulation in recent years. Unproven and untested treatments are often used in clinics that serve numerous clients because “these clinics operate mostly in the private health care sector and typically market their interventions directly to patients over the internet,” according to the World Health Organization.
Advice for People Considering Stem Cell Therapies
Know that the FDA plays a role in stem cell treatment oversight. You may be told that because these are your cells, the FDA does not need to review or approve the treatment. That is not true.
Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefit—or if the product is safe to use.
If you’re considering treatment in the United States:
- Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask the clinical investigator to give you the FDA-issued Investigational New Drug Application number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment—even if the stem cells are your own.
- Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.
Screening and Enrollment Begins- FDA Approved Clinical Trial for Knee Arthritis PSC-CP-001
I am pleased to announce that our clinic is now approved and credentialed for the first of its kind stem cell clinical trial for knee arthritis. For those who are suffering from knee arthritis pain in a single knee, this is a unique opportunity to explore stem cell treatment in an FDA approved research study. This is a tremendous honor since there is a limit often clinics aroundthe country in the clinical trial. Our practice and our professional staff were selected by Personalized Stem Cells due to our leadership and experience in the treatment of orthopedic conditions, and our experience with regenerative medicine.
Personalized Stem Cells, Inc. (PSC) has received approval from the FDA for conducting a clinical trial for the treatment of knee arthritis with stem cells from a patients’ own fat. The clinical trial includes treatment, follow up, and cell storage for potential use in the future if, or when, additional treatments are allowed by the FDA. PSC has FDA inspected facilities, approved processing procedures, quality testing procedures, and cell storage and shipping procedures. More information about the clinical trial can be found HERE.
Call 312-767-5761 if you are interested in being considered for this study and would like to discuss initial screening for your condition to determine if you meet the criteria for this study.
Meanwhile, Google ends stem cell therapy ads due to “rise of bad actors”
- Some say the modern version of snake oil is unproven stem cell treatments, and Google is cracking down on these types of treatments advertising on its site: Amniotic Fluid, Cord Blood, Birth Tissues to list a few.
- “A rise in bad actors” prompted Google to update its policy, according to a statement published Thursday by Adrienne Biddings, a policy adviser for Google Global Product Policy.
- “We’re announcing a new Health care and medicines policy to prohibit advertising for unproven or experimental medical techniques such as most stem cell therapy, cellular (non-stem) therapy, and gene therapy. This new policy will prohibit ads selling treatments that have no established biomedical or scientific basis. The new policy also includes treatments that are rooted in basic scientific findings and preliminary clinical experience, but currently have insufficient formal clinical testing to justify widespread clinical use.”
- These “bad actors” can take advantage of and offer untested, deceptive treatments to individuals who are often sick and desperate, looking for miracle cures. The ban will take effect in October and will impact Google’s ad services, including YouTube and ads Google places on third-party websites.