Stem Cell Options in the United States
The FDA strictly regulates stem cell therapy, limiting what's available domestically. Understanding these regulations helps explain why many Americans travel abroad for treatment.
The FDA's Position
The FDA considers stem cells that are more than "minimally manipulated" or used for "non-homologous" purposes to be drugs requiring approval. This means:
- • Culture-expanding stem cells in a lab = requires FDA approval
- • Using donor cells (not your own) = requires FDA approval
- • IV infusions for systemic treatment = requires FDA approval
- • Treating conditions not related to the cell's origin = requires FDA approval
Result: Most regenerative stem cell treatments available internationally are not legally available in the US outside of clinical trials.
FDA-Approved Stem Cell Uses
These are the only stem cell treatments with full FDA approval.
Bone Marrow Transplants
Hematopoietic stem cells for blood cancers (leukemia, lymphoma) and bone marrow disorders.
Hospital oncology departments
$100,000-500,000 (often insurance covered)
Cord Blood Transplants
Similar to bone marrow for certain blood disorders. Uses donated umbilical cord blood.
Specialized transplant centers
$50,000-250,000 (often insurance covered)
FDA Clinical Trials
Experimental stem cell treatments under strict FDA oversight for specific conditions.
Research hospitals, clinicaltrials.gov
Often free (research funded)
Legal "Gray Area" Treatments
Some regenerative treatments use your own cells with minimal processing. These exist in a regulatory gray area.
PRP (Platelet-Rich Plasma)
Your own concentrated platelets injected into joints or tissues. Not stem cells, but regenerative.
Legal - uses your own blood processed same-day
Autologous Fat-Derived Cells
Fat removed via liposuction and processed same-day. Some clinics do this legally as "same surgical procedure."
Legal gray area - FDA has challenged some clinics
Bone Marrow Aspirate Concentrate
Your own bone marrow concentrated and reinjected same-day for orthopedic conditions.
Legal - uses your own cells with minimal processing
Why Americans Travel Abroad
Understanding what's available internationally that isn't available domestically.
Culture-Expanded Cells
FDA prohibits growing/multiplying stem cells in labs. International clinics can expand cells to get 100x more cells than same-day processing.
Umbilical Cord MSCs
Using donor umbilical cord stem cells is heavily restricted in US. International clinics routinely use these "off-the-shelf" cells.
Systemic IV Infusions
FDA considers IV stem cell infusions as "drugs" requiring approval. International clinics offer IV protocols for systemic conditions.
Treatment for Non-Approved Conditions
Autoimmune diseases, neurological conditions, and anti-aging are not approved uses in the US but are commonly treated abroad.
Beware of US "Stem Cell Clinics"
Many US clinics claim to offer "stem cell therapy" but may be:
- • Operating outside FDA guidelines (potentially illegal)
- • Offering PRP or other treatments mislabeled as "stem cells"
- • Charging high prices for minimally effective treatments
- • Making claims not supported by evidence
The FDA has taken action against US stem cell clinics making unapproved claims. If a US clinic offers what sounds like treatments only available abroad, be very cautious.