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.

Yes, U.S. stem cell treatments are highly regulated by the FDA. They follow strict safety guidelines, ensuring minimal manipulation of cells to preserve their potency and therapeutic effectiveness.

USA clinics comply with strict FDA regulations, ensuring safe, ethical, and effective treatments. Overseas clinics often lack oversight and may use risky practices like excessive manipulation of stem cells.

Overseas treatments may involve unregulated practices, like expanding stem cells without proper safeguards. This increases risks such as infections, tumors, and reduced effectiveness. Additionally, follow-up care may be limited.

In the U.S., stem cell therapy is used to treat orthopedic injuries, autoimmune diseases, neurological disorders, and blood disorders, among others.

In the U.S., stem cells are ethically sourced from bone marrow and adipose tissue. There are no controversial practices, like using embryonic stem cells.

It’s important to choose a U.S.-based clinic that follows FDA-approved protocols, uses minimal manipulation of stem cells, and offers ethical and effective treatment options. Ensure they provide proper follow-up care after your treatment.