Cord and Amnion Tissue Products Good News for Diabetes Foot Ulcers

Atlanta, Ga.-based Amniox Medical Inc., a TissueTech Inc., company, has released the results of a retrospective clinical study of cryopreserved umbilical cord and amniotic membrane (UC/AM) tissue for chronic wound management, a review of the effectiveness of Neox wound allograft in treating patients with chronic diabetic foot ulcers. The findings were presented at Superbones Superwounds East 2016, where the study’s author, Allen Raphael, DPM, was among many top speakers on faculty at the conference.

The retrospective review was conducted on 29 patients presenting with 32 wounds. All wounds were debrided in an operating room or clinic before cryopreserved umbilical cord (Neox wound allograft) was placed directly over the wound, and secured in place with sutures.

Twenty-eight wounds demonstrated complete healing, to achieve a rate of 87.5 percent. Initial wound area was an average of 10.6 cm2, which is substantially larger than a typical diabetic foot ulcer. The average time to healing was 13.79 weeks, and the average number of applications of Neox wound allograft was 1.68. Dr. Raphael concluded that cryopreserved umbilical cord is effective in promoting the rapid healing of chronic, diabetic foot ulcers, suggesting its usefulness as an advanced tissue treatment modality.

“These findings are quite positive for the application of umbilical cord allograft for diabetic foot ulcers,” Dr. Raphael said. “A close review of this data in comparison to other published studies also suggests more frequent applications most likely translates to faster healing, even considering larger initial wound size. High levels of the HC-HA/PTX3 protein complex in the umbilical cord appear to play a central role in successful healing in these cases. The tissue’s demonstrated effectiveness and ease-of-use make it a valuable option for these patients and the physicians overseeing their care.”

“The body of clinical evidence regarding umbilical cord tissue in regenerative healing is continuing to grow further,” said Tom Dugan, CEO of Amniox Medical. “If one compares this finding of an 87.5 percent healing rate with rates published for multiple alternatively processed amniotic membrane options, including for instance bioengineered skin substitutes and cryopreserved or dehydrated amniotic membrane, this is clearly a positive alternative, especially considering the larger-than-typical average wound size and fewer applications required for healing. Coupled with the storage flexibility Amniox tissues offer, and the ease of handling and application, the benefits are magnified.”

Amniox’s parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. In utero, wound healing occurs rapidly and with minimal scarring. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. Amniox uses its proprietary Cryotek process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 200,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical makes regenerative therapies processed from umbilical cord and amniotic membrane using its proprietary Cryotek technology.