Postnatal Birth Tissue Procurement Safety Standards
Postnatal birth tissue is the source for regenerative medicine products. The process to donate birth tissue is voluntary; however, there is a rigorous process to ensure the donated tissue meets eligibility criteria established by the FDA.
Lone Peak Biologics Utilizes Local Procurement
Lone Peak Biologics’ products are made from locally-procured postnatal birth tissue in Utah, which the CDC cites has one of the lowest rates of communicable and sexually-transmitted diseases in the United States. Mothers who donate their birth tissue are healthy and deliver babies via Caesarean section in a sterile environment (operating room).
Additionally, locally procured when birth tissue can be manufactured within an hour of recovery, resulting in higher yields of viability and cell count. Most regenerative medicine manufacturers purchase their birth tissue from recovery agencies outside of the state and have it shipped, often several days after the birth.
Our Donor Eligibility Process
All donors are screened, and testing is performed to ensure the donated birth tissue is free from risk factors for infection due to relevant communicable disease agents and diseases.
The process begins with an informed consent form signed by the mother/donor of the tissue. A medical and social history interview is performed to evaluate risk and the health of the donor. Previous to delivery, the mother goes through a physical evaluation assessment to ensure she is healthy.
A blood test is performed within seven days of the birth of the baby to screen for communicable diseases. Donor blood testing is performed by an independent lab who complies with CLIA standards and is registered with the FDA, certified by CMS, and accredited by CAP and AABB. Laboratory testing is performed with FDA licensed tests to ensure the donor is screened for HIV I/II, HBV, HCV, Treponema pallidum, HTLV I/II, WNV/NAT, and Cytomegalovirus (CMV).
Commonly Asked Questions:
Are there risks to donating birth tissue?
No, there are no significant risks when donating birth tissue. The amount of blood drawn during qualification is small enough that it will not affect your health, and the placenta is not needed by the baby anymore after birth. If your doctor decides that the birth tissue requires evaluation, then it must be used in that manner.
Why donate birth tissue?
Mothers opting to donate birth tissue play a significant role in developing the products used in regenerative medicine. The donated birth tissue will aid in tissue repair and regeneration, development and breakthroughs in cardiovascular, central nervous, gastrointestinal, renal, orthopedic, and hematopoietic treatment applications.
Are there costs associated with donating birth tissue?
Since birth tissue is typically discarded after delivery, there is no cost to the donor in any aspect of the donation. Furthermore, Utah Cord Bank cannot pay donors for their donation, and participation must always be voluntary.
How do healthcare professionals feel about birth tissue recovery?
Healthcare professionals generally understand the value of tissue donation and are supportive of the practice. Lone Peak Biologics is fully compliant with FDA regulations, and has passed strict FDA inspections. The company prides itself on its state-of-the-art technology and its ability to provide products of the highest quality in the industry. Our company has developed innovative processes and safety protocols, which allow us to offer products of high cellular viability and safety standards. Because of these safety and quality standards, Lone Peak Biologics continues to lead the way in birth-tissue allograft in the field of regenerative medicine.