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Trial Testing Amniotic, Umbilical Grafts to Heal Wounds

Pregnancy health (CDC)

(CDC.gov)

29 July 2014. A new clinical trial is testing skin grafts from amniotic and umbilical cord tissue as a treatment for chronic wounds, in this case diabetic foot ulcers. The skin grafts are made by Amniox Medical Inc. in Atlanta, Georgia, adapted from a technology developed by Tissue Tech Inc. in Miami.

Amniox Medical provides therapies derived from human amniotic membranes and umbilical cords that have regenerative medical properties as a result of their role in the development of fetuses. The amniotic membrane is the inner layer of the placenta that grows in parallel and shares cells with the fetus. The umbilical cord provides blood to the fetus and is made from layers of amniotic membrane and a gelatinous substance called Wharton’s Jelly that is also a source of stem cells and growth factors.

The company adapts a process developed by Tissue Tech Inc. for preserving donated amniotic and umbilical tissue for regenerative medicine. In this process, donated tissue is deep frozen, which Amniox and Tissue Tech say preserves the functions and structure of the original cells better than dehydration, an older technique. Donors are mothers who give birth through Cesarean section, and give their consent after social, physical, and medical screening.

The clinical trial is testing Amniox Medical’s Neox Cord 1K wound coverings made from processed amniotic and umbilical tissue with patients having non-healing diabetic foot ulcers. These wounds are open sores usually found on the bottom of feet of about 15 percent of people with diabetes, which can become infected and lead to amputations. Diabetes is the leading cause of lower-extremity amputations in the U.S.

The trial is enrolling some 30 adult patients in Arizona, California, and Georgia who are randomly assigned to receive either a Neox Cord 1K matrix wound graft or a pressure bandage, the standard of care. Patients are monitored over 12 weeks and assessed primarily for the safety of the therapy, measured by adverse reactions, and closure of the wounds determined by expert panel evaluating photographs of the ulcers. Researchers are also recording the number of applications needed and amount of time needed to close the wounds.

Patients receiving pressure bandages will be offered the Neox Cord 1K treatments if their foot ulcers do not heal after 12 weeks. Their progress will then be evaluated for an additional 12 weeks similarly to the patients originally receiving the treatments.

The trial began recruiting participants last month and is expected to be completed in June 2015.

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