Stem Cell Treatment Abroad vs USA: What Patients Should Compare

Allogenic Stem Cell and Exosome Information

Certificate of Analysis (COA) and Donor Compliance Overview

1. Product Testing Overview

All donor tissue is screened and qualified under FDA CFR 21 Part 1271. The following testing and qualification measures were performed:

• Donor Qualification Process Includes:
  • Medical history and social history review
  • Physical examination
  • Raw product recovery documentation
  • Informed consent under IRB-approved protocol
• Communicable Disease Testing: The donor tested negative/non-reactive for the following conditions:

• Testing Methods:
  • UltrioElite: HBV, HCV, HIV-1/2
  • All lab testing performed within 7 days of cord blood recovery
  • Testing conducted in CLIA-certified or equivalent FDA-compliant laboratories
  • FDA-approved test kits utilized for all disease screening

1. Donor Screening Protocol

Donor qualification and tissue recovery are fully compliant with FDA 21 CFR 1271 regulations and overseen by Institutional Review Boards (IRBs).

• Donor Recruitment and Consent:
  • All donors are voluntarily consented under IRB-approved forms
  • Staff are HIPAA-trained and IRB-trained for patient interaction
  • Recruitment is inclusive of all ethnic groups
• Donor Eligibility Criteria:
  • Age range: 18–45 years
  • No high-risk factors based on health and social history
  • Must test negative for all infectious diseases listed above
  • If donor eligibility is not completed, tissue is discarded per SOP #CFRM-DOC-037
• Pre-Donation Screening Steps:

1. Sign the Informed Consent Form
2. Undergo a comprehensive medical examination
3. Complete a medical and social history interview

• Purpose of Screening: This process exists to prevent the transmission of communicable diseases as dictated by 21 CFR 1271 Subpart C – Donor Eligibility.

III. Regulatory and Quality Compliance

• All tissue recovery is performed by contract organizations approved under IRB protocol
• All specimens are processed and stored under standard operating procedures (SOPs)
• All donor and laboratory documentation is retained per FDA and state regulatory requirements

Notes:

• Zika Virus and SARS-CoV-2 NAT testing are performed only if applicable per exposure guidelines.
• Donors with incomplete eligibility or failed screenings are disqualified from product use.

No, you don’t need to travel overseas for stem cell treatments. High-quality Mesenchymal Stem Cell (MSC) therapies are available in the U.S., and they are regulated for safety and effectiveness.

FDA-approved stem cell products are limited and generally involve blood-forming stem cells for hematopoietic conditions. Regenerative uses such as orthopedic or chronic pain care are generally not FDA-approved and should include clear disclosure and informed consent.

Patients should compare physician credentials, product sourcing, lab documentation, regulatory disclosures, total travel cost, medical records, and the follow-up plan. The best choice depends on transparency, candidacy, and continuity of care rather than a blanket claim that one country is superior.

Ask what product is being used, where it is sourced, whether it is FDA-approved for your condition, who performs the procedure, what lab documentation is available, what is included in the quoted price, and who manages concerns after you return home.

Florida SB 1768 allows licensed Florida physicians to provide certain stem cell therapies related to orthopedics, wound care, or pain management with required disclosures when therapies are not FDA-approved. It does not make every use legal or override federal law.

Patients should ask for sourcing documentation, testing information, and any certificate of analysis that helps them understand what product is being used and how it was handled before treatment.

Follow-up care gives patients a clear plan for questions, symptoms, recovery guidance, medical records, and coordination with a physician after the procedure, especially if concerns arise after travel.