Stem Cell Donor Criteria

What kind of screening is involved before birth tissue is accepted for processing?

All tissues are sourced from live, healthy U.S.-based donors after elective C-section delivery. Donors are screened and selected based on stringent criteria (see Question #12-14 for detailed info).

Note: Donors who have received covid-19 vaccines are NOT accepted.

Potential donating mothers are examined periodically by their ob/gyn physician throughout pregnancy, and are required to go through necessary testing. 

Before time of birth, if a mother chooses not to store their baby's umbilical cord for private use, she is asked if she would like to donate birth tissue (placenta and umbilical cord). When their answer is yes, the mother is asked to complete an extensive questionnaires, which screen for infectious disease exposures, alcohol/ drug/smoking or other toxic exposures, medication use, travel history, any family history of heritable and non-heritable diseases, such as cancer, autoimmune diseases, blood disorder, etc., partner's health history (baby's father), as well as any prenatal test abnormality of the baby. 

Informed consent is obtained, and the final acceptance of the donor tissue is determined by a licensed physician. 

Once the donor tissue is accepted, the donor's blood is tested for relevant communicable diseases in a laboratory certified under Clinical Laboratory Improvement Amendments of the 1988 (CLIA) or equivalent and registered with the FDA for donor testing. Donor screening, tissue collection and processing protocols meet or exceed applicable FDA regulations and industry standards. 

A licensed physician must review the results of testing and determine that the donor has met all eligibility requirements. The physician utilizes available relevant information which may have included, but not limited to: donor interview, medical/ hospital records, donor physical assessment, infectious disease test results, radiology/pathology and other records if available and pertinent. Recipient records must be maintained for the purpose of tracing tissue post-transplant per JCAHO and FDA requirements.

Can you explain the donor eligibility criteria to me in greater detail? 

1) Eligibility A donor is determined to be eligible if acceptable criteria is met for the following: 

  • An Informed Consent Form (GLP-DOC-0045) is completed and signed by the Donor. 

  • Medical records do not identify areas that would cause the donor to be ineligible per the criteria identified in the FDA Guidance Document - Eligibility Determination for Donors of HCT/Ps (August 2007) or within the ineligibility criteria in this procedure. 

  • The Donor Information and Health History Form (GLP-DOC-0046) does not identify areas that would make the donor ineligible. 

  • Communicable disease testing is performed by a CLIA certified lab and includes negative results for required testing. 

  • The Physical Evaluation Form (GLP-DOC-0047) does not identify physical evidence of sexually transmitted diseases, syphilis, non-medical percutaneous drug use such as needle tracks, disseminated lymphadenopathy, unexplained oral thrush, jaundice, sepsis, large scabs, severely necrotic lesions, etc. 

  • The recovery location of the donated HCT/P was suitable as indicated on the Postnatal Birth Tissue Recovery Form (GLP-DOC-0048). 

2) Ineligibility Any indication that a donor has responded as participating in, admission to or observing of the following, results in a rejection of the donor’s postnatal birth tissue donation. 

  • Persons who have injected drugs for a non-medical reason in the preceding 5 years, including intravenous, intramuscular or subcutaneous injections (risk factor for HIV, Hepatitis B and Hepatitis C). 

  • Persons with hemophilia or other related clotting disorders who have received human-derived clotting factor concentrates on the preceding 5 years (risk factor for HIV, Hepatitis B and Hepatitis C). · A donor who received clotting factors once to treat an acute bleeding event more than 12 months ago may be eligible to donate, based on approval from the medical director. 

  • Persons who have engaged in sex in exchange for money or drugs in the preceding 5 years (risk factor for HIV, Hepatitis B and Hepatitis C). 

  • Persons who have had sex in the preceding 12 months with any person who has HIV infections, including a positive or reactive test for HIV virus, Hepatitis B infection or clinically active (symptomatic) Hepatitis C infection. 

  • Persons who have been exposed in the preceding 12 months to known or suspected HIV, HBV and/or HCV-infected blood through percutaneous inoculation (e.g., needle stick) or through contact with an open wound, non-intact skin or mucous membrane. 

  • Persons who have been in juvenile detention, lock up, jail or prison for more than 72 consecutive hours in the preceding 12 months (risk factor for HIV, Hepatitis B and Hepatitis C). 

  • Persons who have lived with (resided in the same dwelling) another person who has Hepatitis B infection or clinically active (symptomatic) Hepatitis C infection in the preceding 12 months. 

  • Persons who have undergone tattooing, ear piercing or body piercing in the preceding 12 months, in which sterile procedures were not used (e.g., contaminated instruments and/or ink were used, or shared instruments that had not been sterilized between uses were used. 

  • Persons who have had a past diagnosis of clinical, symptomatic viral hepatitis after their 11th birthday, unless evidence from the time of illness documents that the hepatitis was identified as being caused by Hepatitis A virus, Epstein-Barr Virus (EBV) or Cytomegalovirus (CMV). 

  • Persons who have had smallpox vaccination (vaccinia virus) in the preceding 8 weeks. 

  • Persons who acquired a clinically recognizable vaccinia virus infection by contact with someone who received the smallpox vaccine (i.e., touching the vaccination area or the scab, including the covering bandages, or touching clothing, towels, or bedding that might have come into contact with an un bandaged vaccination area or scab). 

  • Persons who have had a medical diagnosis or suspicion of West Nile Virus (WNV) infection (based on symptoms and/or laboratory results, or confirmed WNV viremia). 

  • Persons who have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days 

  • Persons who have been treated for or had syphilis within the preceding 12 months. 

  • Persons who have been diagnosed with vCJD or any other form of CJD (Creutzfeldt-Jakob disease) or persons who are at increased risk for CJD. 

  • Donors are considered to have an increased risk for CJD if they have received a non-synthetic dura mater transplant, human pituitary-derived growth hormone, or have one or more blood relatives diagnosed with CJD. 

  • Persons who have been diagnosed with dementia or any degenerative or demyelinating disease of the central nervous system or other neurological disease of unknown etiology. 

  • Blood tests with a reactive result for: HIV Type I / II, HBV, HCV, Treponema / Syphilis, HTLV. 

  • Physical evidence of sepsis, syphilis, percutaneous drug use such as needle tracks, recent tattooing, ear piercing or body piercing. 

  • Persons who received any of the covid-19 vaccines. 

3) Additional Review for Eligibility 

Any indication that a donor has responded as participating in, admission to or observing of the following, results in an additional review by the Medical Director for eligibility determination. If approved, a written justification shall be provided with the eligibility determination rationale. 

  • Blood tests with a reactive result for Cytomegalovirus (CMV) must include additional testing, specific to CMV IgG and CMV IgM. The results below indicate donor eligibility: 

    • CMV IgG detected, donor is eligible 

    • CMV IgM detected, donor is not eligible 

  • Had any one of the following cancers, either as the donor or someone within the family: Brain or other nervous system, bone or joint, kidney, thyroid, Hodgkin’s lymphoma, Non-Hodgkin’s lymphoma, acute or chronic myelogenous / myeloid leukemia, skin cancer.

  • A donor who received clotting factors once to treat an acute bleeding event more than 12 months ago may be eligible to donate, based on approval from the medical director.

  • Donors who have blood disease or disorders, either as the donor or within the family. 

  • Have a history of insulin independent diabetes, either as the donor or within the family. 

  • Have one of the following autoimmune disorders, either as the donor or someone within the family: Crohn’s diseases, ulcerative colitis, lupus, multiple sclerosis, rheumatoid arthritis, sarcoidosis, polyarteris nodosa or scleroderma.

  • Donors who have a diagnosis of delirium (e.g., delirium caused by toxic/metabolic diseases or recent head trauma) would not necessarily be considered to have a diagnosis of dementia and should be evaluated by the Medical Director. 

  • (HCT/Ps from donors with dementia confirmed by gross and microscopic examination of the brain to be caused by cerebrovascular accident or brain tumor and who are confirmed not to have evidence of TSE on microscopic examination of the brain may be acceptable based on an evaluation by the Medical Director). 

  • Persons who have had a medical diagnosis or suspicion of Zika virus infection (based on symptoms and/or laboratory results) within the last four weeks. 

  • Persons who have had a medical diagnosis or suspicion of SARS (based on symptoms and/or laboratory results) within the last 28 days. 

  • Persons who have ever been exposed to Ebola.

  • Persons who spent three months or more cumulatively in the United Kingdom from the beginning of 1980 through the end of 1996.

  • Persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996. 

  • Persons who spent 5 years or more cumulatively in Europe from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996). 

  • Persons who received any transfusion of blood or blood components in the U.K. or France between 1980 and the present

  • Persons or their sexual partners who were born or lived in certain countries in Africa (Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria) after 1977 (risk factor for HIV group O).

  • Persons who have received a blood transfusion or any medical treatment that involved blood in an African country, after 1977 (risk factor for HIV group O). 

What infections have been screened?

Donated human tissue is deemed qualified for transplantation by meeting the following criteria: 

  1. Results from the donor pre-screening lab tests specify the donor to be free from risk factors and active infections of applicable communicable disease agents and diseases required by the FDA. 

  2. All tissues are obtained and processed using sterile technique. Birth tissue are obtained only through Cesarean section (thus assuring sterility) 

  3. Donor results from the pre-screening lab test for applicable communicable disease agents must meet the following guidelines/criteria: 

  • USP 71 Sterility Guidelines (All fungi, mold, yeast, bacteria) in accordance with AATB and FDA 

  • Endotoxin guidelines in accordance with AATB and FDA 

  • Viruses and Blood and Tissue borne pathogens in accordance with AATB and FDA 

  1. Bacillus species not anthracis (agent of anthrax). 

  2. Coagulase Negative Staphylococcus (CNS) to rule out Staphylococcus aureus. 

  3. Alpha-Hemolytic Streptococcus not S. pneumoniae. 

  4. Gamma-Hemolytic Streptococcus not Enterococcus. 

  5. Beta Hemolytic Streptococcus Group A (Strep. pyogenes), B (Strep. agalactiae), C, F, G will be reported with their Lancefield antigen group. 

  6. Aerobic coryneform bacteria reported as “Coryneform Bacteria.” 

  7. All remaining organisms will be reported to genus if possible, otherwise their Gram stain morphology and related information will be listed. (i.e. Gram negative rod, oxidase positive) 

  8. Fungal isolates will be listed as “Yeast Isolated” or “Fungus Isolated” without an identification.

Additional Fungal Isolate testing: 
Fungus Identified to the genus level 
Yeast Identified to species level 

  • MRSA / VRE Isolate testing: 

  • MRSA testing required for Staphylococcus aureus isolates

  • VRE testing required for Group D Enterococcus isolates 

  • (MRSA and VRE testing are performed using screen agar or disk diffusion methods.) 

Additional Isolate testing: 

  • HIV I/II Ab: Human Immunodeficiency Virus Types I & II Antibody 

  • RPR: Syphilis 

  • HIV/HCV/HBV NAT: Human Immunodeficiency/Hepatitis C/B 

  • HBs Ag: Hepatitis B Surface Antigen 

  • HCV Ab: Hepatitis C Virus Antibody 

  • HTLV I/II: Human T-Cell Lymphotropic Virus Antibody 

  • CMV total Antibody 

  • West Nile Virus NAT 

  • Zika NAT 

  • Borrelia burgdorferi: Lyme Disease 

  • Candida albicans 

  • Aspergillus brasiliensis 

  • Bacillus subtilis 

  • Pseudomonas aeruginosa 

  • Staphylococcus aureus 

  • Clostridium species 

  • E. coli 

4) At the time of procurement, cultures of the tissue are taken and grown out for evaluation. Donor tissue with cultures testing positive for the following microorganisms are rejected: 

  • clostridium 

  • streptococcus pyogenes (group A strep.) 

  • enterococcus 

  • fungi (mold or yeast phase)

5) Allograft Release Testing: testing must also be negative for Endotoxin and BioBurden testing before the final product can be released for use clinically. 

6) Also, screening for exposure to other viruses or parasites may have been completed. A negative/nonreactive result is not required. All results are evaluated on a case by case basis by medical director: 

  • Epstein Barr Virus EBV Ab (IgG & IgM) 

  • Toxoplasma gondii Toxoplasma AB (IgG & IgM) 

  • Trypansoma cruz T.Cruzi Ab (IgG & IgM)