Where do our Stem Cells come from?
Stem Cells are derived from donated placentas from healthy mothers delivering babies by C-section. Our allograft products deliver industry-leading quality in a variety of form factors.
UMBILICAL CORD BLOOD
Umbilical Cord Blood Stem Cells are derived from the umbilical cord and the placenta and are donated by mothers of normal healthy live birthed babies. This cord blood contains predominantly Hematopoietic Stem Cells (HSCs) and some MSCs. MSCs are capable of replacing the body’s defective “connective tissue matrix”, which when healthy, is is a natural interconnected system of Collagen, Growth Factors, and bioactive molecules that provide the infrastructure, integrity and regeneration of the body’s various tissues. These components participate in an elaborate cellular signaling system for repair and regeneration.
The Cord Blood HSCs (Hematopoietic or “blood forming” Stem Cells) can be used to treat leukemia, blood and bone marrow disorders and immune deficiencies (homologous use).
All donors are screened to ensure they meet the eligibility criteria established by the FDA. Blood testing is performed by an independent lab to ensure the donor is screened for communicable diseases including, HIV 1 & 2, HBV, HCV, Treponema pallidum, HTLV I/II, WNV/NAT and Cytomegalovirus (CMV). Additional donor screening includes a medical history interview, physical examination, behavioral risk assessment, and information from other sources or records which may pertain to donor suitability.
Our human tissue products deliver industry-leading quality in a variety of form factors. The extraction process is highly delicate, preserving natural elements and maximizing the density of viable cellular materials.
STANDARDS & REGULATIONS
Our products go through comprehensive clinical and laboratory testing to ensure they are safe and effective for patient use. We comply with US FDA regulations for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P) identified in 21 CFR Part 1271 and Section 361 of the Public Health Service Act. Compliance with these regulations ensures the delivery of quality allograft products.