Regulatory & Safety
Our Commitment
- Compliant with FDA Current Good Manufacturing Practice (CGMP) and FDA Good Tissue Practice (GTP)
- Produced in sterile FDA compliant laboratory
- Processed with the highest safety, testing and quality control
- Participating hospitals invite mothers expecting normal, healthy births to donate the resulting umbilical cord. This tissue was once disposed of as waste, but is now considered to be an excellent source of high-quality stem cells.
- At the time of birth, a specialized nurse enters the delivery room to carry out the extraction procedures.
- With the mother’s informed consent, the umbilical cord is clamped off when the baby is born.
- The byproduct is then extracted from the cord and taken to our sterile lab, which then processes the cell allograft for therapeutic use.
- Our lab specialists screen the cords under AATB standards and process the byproduct to extract the stem cells.
- Unlike other regenerative medicine companies we extract our units in standardized concentrations for accurate treatment doses.
- We ship in single-dose preparations on dry ice for maximum preservation.
PATIENT BENEFITS
- Harness restorative abilities of umbilical cord derived cells and growth factors
- Non-invasive regenerative treatment that may have the ability to replace surgery
- Relief and improvement for a range of conditions, including joint injury, arthritis, heart disease, and autoimmune disease.