May 18, 2020
Pilot Study Shows Adjunctive Use of Umbilical Cord Allograft May Improve Clinical and Functional Outcomes Following Arthroscopic Repair of Talar Osteochondral Defects
Cryopreserved umbilical cord allograft is a novel treatment option due to its unique properties promoting a regenerative wound healing environment
Miami, FL – May 18, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the results from a prospective, single-center, pilot study to determine whether adjunctive use of cryopreserved Umbilical Cord (cUC) allograft (Clarix® 1K) could improve clinical and functional outcomes following arthroscopic repair of a talar Osteochondral Defect (OCD).1 A talar OCD is an injury to the cartilage and underlying bone of the talus (dome-shaped top of the ankle bone) within the ankle joint. This study was published in the peer-reviewed journal Foot & Ankle Specialist.
This pilot study, conducted by Dr. Murray Penner, MD, et al, evaluated the use of cryopreserved UC allograft as an adjunct during arthroscopic treatment of OCD to help reduce postoperative pain and inflammation, improve range of motion, and accelerate recovery. A total of ten patients with talar OCDs who failed non-operative treatment were enrolled in the study. Clinical and functional outcomes were assessed using the Ankle Osteoarthritis Scale (AOS) and Visual Analog Scale (VAS) pain scores at 6, 12, 24, and 52 weeks postoperatively.
Results showed a consistent improvement in both AOS and VAS pain scores. This cryopreserved umbilical cord allograft was used in this pilot study because of its known therapeutic value derived from its anti-inflammatory and anti-scarring properties noted in peer-reviewed publications.2
“A large percentage of patients with OCDs require surgical intervention because up to 50%of all patients fail to improve with conservative treatment.3 Adjunctive use of Clarix 1K, the cryopreserved umbilical cord allograft used in this study, during arthroscopic repair of OCD may lead to clinical and functional improvement for this patient population,” said Herbert Slade, MD, Chief Medical Officer at TissueTech. “By modulating inflammation, a cryopreserved UC allograft may help expedite healing, and manage scar tissue formation in arthroscopic repair of talar osteochondral defects in the ankle joint. We are encouraged by these results with a limited sample size and look forward to further controlled, prospective studies with a larger sample size to help confirm these clinical benefits.”
Musculoskeletal diseases affecting the foot and ankle are common and can result in debilitating pain, chronic disability, and significant health care costs. According to the National Institutes of Health, the estimated economic burden of foot and ankle surgery in the Medicare population alone is approximately $11 billion each year.4 Finding that adjunctive use of cryopreserved umbilical cord allograft could improve clinical and functional outcomes following arthroscopic repair of an OCD is very promising for orthopedic surgeons and their patients.
About Amniox Medical, Inc.
Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane & umbilical cord allografts) processed using TissueTech’s proprietary CryoTek® cryopreservation technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on our Website, Facebook, LinkedIn and Twitter.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://biotissue.com/.