Just4Children does support fundraising for FDA approved Stem Cell Therapy.
Some stem cell treatments currently offered by clinics are not FDA-approved and may pose significant risks.
FDA-approved stem cell therapies
The FDA has approved a limited number of stem cell therapies for specific conditions, which have undergone rigorous research and testing.
- Hematopoietic (blood-forming) stem cell transplants: This is the most common and well-established form of stem cell therapy. These cells, derived from bone marrow, peripheral blood, or umbilical cord blood, are used to treat patients with blood cancers like leukemia and certain blood or immune system disorders.
- RYONCIL (remestemcel-L): In late 2024, the FDA approved this mesenchymal stromal cell (MSC) therapy for children under 12 with steroid-refractory acute graft-versus-host disease (aGVHD). This was the first FDA-approved MSC therapy.
- Other specific products: The FDA maintains a list of approved cellular and gene therapy products on its website.
Unapproved stem cell therapies
The vast majority of stem cell treatments advertised by clinics are not FDA-approved and are not compliant with regulatory standards. The FDA has issued strong warnings about these unregulated products, which are often marketed for a wide range of conditions without proof of safety or effectiveness.
Before considering a stem cell treatment, it is crucial to do your research and ask key questions.
- Consult a medical professional: Discuss the therapy with a qualified doctor who can provide reliable information.
- Ask for the FDA status: Your provider should be able to tell you if the FDA has reviewed or approved their specific treatment.
- Check for a clinical trial: If the therapy is still under investigation, ask for the Investigational New Drug (IND) application number. You can verify this on the website ClinicalTrials.gov to ensure it is a legitimate, FDA-regulated study.
- Be skeptical of misleading claims: Be cautious of clinics that make broad claims about “FDA-approved” status for unproven procedures. Some may use deceptive language to imply legitimacy.