Data demonstrate pain and physical function scores significantly improved from baseline at all follow up points with average pain reduction of nearly 52 percent at 24 weeks.
Miami, FL – January 15, 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 single-center, prospective, investigator-initiated pilot study titled “Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis.”
The study was conducted on 20 patients ranging from 52 years old to 78 years old living with knee osteoarthritis (OA). Ramon Castellanos, MD, served as lead investigator for this study designed to evaluate the short-term safety and effectiveness of CLARIX FLO. Patients were considered to have symptomatic knee OA if they had knee pain >40 mm, as determined by averaging the five pain subscale scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). These five pain subscale scores measure the patient’s level of pain walking on a flat surface, level of pain going up or down stairs, level of pain at night while in bed, level of pain sitting or lying, and level of pain standing upright. The WOMAC is a self-administered questionnaire that has three subscales that measure pain (WOMAC-A, five questions), stiffness (WOMAC-B, two questions), and physical function (WOMAC-C, 17 questions), with higher scores indicating worse status; it has been validated for knee OA.
“This indicates that CLARIX FLO may be a viable alternative to nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics, which have known cardiovascular or gastrointestinal effects when used on a long-term basis,” said Herbert B. Slade, MD, Chief Medical Officer of TissueTech. “Study results showed that the usage of NSAIDs for pain management significantly decreased from 10 patients to two patients at 24 weeks, and five of the nine patients taking an opioid-based prescription medication in the study discontinued usage of opiates within 24 weeks.”
Study data showed that knee OA pain significantly decreased from 74.3 ± 17.2 at baseline to 45.0 ± 25.4 at six weeks (P < 0.01), 35.4 ± 26.6 at 12 weeks (P < 0.001), and 37.4 ± 26.7 at 24 weeks (P < 0.001). This pain reduction was associated with a significant improvement in physical function (WOMAC-C) at all time points (P < 0.05) and stiffness (WOMAC-B) at 12 weeks (P = 0.01). Eleven patients received a second injection, which was significantly correlated with body mass index >30 kg/m2 (P = 0.025). The magnetic resonance imaging evaluation of the overall population revealed an improvement in the severity of bone marrow lesions in seven patients. No adverse events were observed.
“Prescription opioid misuse has contributed heavily to today’s opioid epidemic,” said Amy Tseng, President, and CEO of TissueTech. “According to the Centers for Disease Control and Prevention, almost 400,000 people died between 1999 and 2017 from an overdose involving any opioid, including prescription and illicit opioids.1 CLARIX FLO holds great promise for physicians seeking a safe, nonopioid treatment option when treating chronic pain as a result of a degenerative joint disease such as knee osteoarthritis.”
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) 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., is a scientific and market leader in the field of regenerative medicine and manufactures a broad range of ocular, surgical, wound care, and soft tissue products marketed under its subsidiaries, Amniox Medical and Bio-Tissue. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and Scheffer C.G. Tseng, MD, PhD, the company’s co-Founder and Chief Scientific Officer, published more than 360 peer-reviewed studies supporting its technology platform. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.
- Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths – United States, 2013-2017. WR Morb Mortal Wkly Rep. ePub: 21 December 2018.