Donor Screenings / Donor Eligibility
Each Stemell® Cord Blood, Cord Tissue, Amniotic Fluid, Amniotic Tissue donors completes a series of questions to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and undergoes a physical examination by a healthcare professional which includes a blood draw for serology testing. Additionally, tissue cultures taken following recovery are analyzed to detect the presence of bacterial contaminants. All test results for serology, bacteriology and infectious disease are reviewed prior to the release of the donor tissue. Only tissue from donors with acceptable test results in conformance with Stemell® standards as well as the standards of all state and federal regulatory bodies is released to be processed.
Stemell® has thoroughly reviewed the FDA Chagas Disease Guidance and has made updates to the Company’s donor eligibility process to continue to be in compliance with all requirements. The Company also includes all AATB recommendations on donor eligibility for Chagas disease transmission risks in the Stemell® Quality System. The Company has devoted numerous resources and energy to assuring that all our donors are fully screened for any risk of infectious disease. Also, the Company’s allografts products are specifically processed to ensure the dual goals of maximizing patient safety and retaining the native characteristics of the Cord blood/tissues and amniotic membrane.
To ensure patient safety, donor screening and testing is performed for each donor mother. Donor screening includes a review of both the donor's medical and social history to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and to ensure that the donor has not shown signs or symptoms of illnesses.
The DONATED HUMAN TISSUE has been determined to be suitable for transplantation by a licensed physician, the Medical Director of the Tissue Bank. The donor has been deemed free from risk factors for and clinical evidence of infection due to relevant communicable diseases and other exclusionary disease conditions through review of donor records, including medical/behavior risk assessment, medical records, and a recent physical examination. Additionally, testing of a qualified blood sample indicates that the donor is nonreactive or negative for the following communicable disease markers:
• Lyme disease
• HIV I
• HIV II
• HTLV I
• HTLV II
• Hepatitis B
• Hepatitis C
• Cytomegalo virus
• West Nile Virus
• ABO Blood group and Rh Type
• Chagas Disease (T-Cruzi)
• Chlamydia Trachomatis
• Neisseria gonorrhoeae
• CAPTIA Syphilis (T.Pallidum)-G
Part of Stemell® Legacy, we want to go beyond the markets standards for all patients out there seeking therapeutics options. We are here only for one reason, deliver what patients are really deserve which are Quality, Integrity and commitment.