Allogenic Stem Cell and Exosome Information
Certificate of Analysis (COA) and Donor Compliance Overview
- 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:
Infectious Agent | Test Type |
Cytomegalovirus (CMV) | Total Antibody |
Hepatitis B | Core Total Ab, Surface Ag |
Hepatitis C | HCV Antibody |
HIV | HIV-1/HIV-2 Plus O, NAT |
HTLV I/II | Antibody |
Syphilis | Non-Treponemal Screening & Treponema pallidum |
West Nile Virus (WNV) | NAT |
Chagas’ Disease | T. cruzi ELISA |
Zika Virus | NAT (if applicable) |
SARS-CoV-2 | PCR/NAT (if applicable) |
SARS-CoV-2 Vaccine | Documented |
- 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
- 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:
- Sign the Informed Consent Form
- Undergo a comprehensive medical examination
- 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.
