Feasibility study meets primary endpoints and paves the way for a pivotal study in 2019
Houston, TX, USA, December 12, 2018 – InGeneron, Inc., a regenerative medicine and cell therapy company, announced today the successful conclusion of its U.S. Food and Drug Administration (FDA)-approved feasibility study for partial rotator cuff tears. Analysis of patient data one year after treatment indicates the company’s autologous point-of-care cell therapy is safe and well-tolerated. A partial rotator cuff tear is a degenerative and often chronic indication found in the shoulder. It is one of the most common orthopedic impairments of a person’s upper extremities and is estimated to affect more than one million patients in developed economies annually.
“In addition to the study’s successful demonstration of safety, patients who received InGeneron’s regenerative cell treatment reported a reduction in pain and improvement in function,” said Glenn Winnier, PhD, Chief Scientific Officer of InGeneron. “This is very encouraging because it represents a first signal for clinical efficacy of the therapy with our platform.”
InGeneron’s FDA-approved feasibility study investigated the safety and efficacy of using adipose (fat)-derived regenerative cells to treat partial thickness rotator cuff tears involving a partial tear in the supraspinatus tendon. The cells were isolated from the patient’s own adipose tissue and processed with InGeneron’s proprietary technology at the bedside. InGeneron conducted the trial in collaboration with its clinical partner Sanford Health and enrolled a total of 18 patients ranging in age from 40 to 73 years. The allocation of treatment was randomized and single-blinded, with two-thirds of the patients receiving the adipose-derived regenerative cell injections and one-third receiving a cortisone injection as a control group. Follow-up took place at twelve months post treatment and included MRI (magnetic resonance imaging) of the patient’s shoulder. The results are being prepared for peer-reviewed publication.
“Increasingly, individuals who endure unmet medical needs in orthopedic conditions feel that they can only resort to conventional pain medication or costly surgeries,” said Angelo Moesslang, PhD, Chief Executive Officer of InGeneron. “The results of our rotator cuff tendinopathy feasibility trial provide hope that the therapy may offer a new treatment option for patients. This is encouraging as we will proceed with a pivotal study, which will be among the largest regenerative cell therapy trials in this indication to date.”
Following the positive outcome of this feasibility trial, InGeneron will continue its clinical program in rotator cuff tendinopathy with a double-blinded, multi-center pivotal study aiming to recruit more than 200 patients. The company anticipates enrolling the first patients in 2019. More information about the study is provided on ClinicalTrials.gov.
About the Transpose® RT System and FDA approved clinical trials
InGeneron’s Transpose® RT cell therapy platform consists of a processing unit, a set of disposables and Matrase®, a proprietary enzyme mixture. The platform allows the isolation of regenerative cells from the patients’ own adipose tissue at point-of-care in less than 90 minutes for same-day treatment. The cells are re-administered into the patient’s damaged tissue by injection under ultrasound or fluoroscopic guidance.
The Transpose® RT System is being investigated in several FDA-approved clinical trials and is currently available in the U.S. for research use only. More information on InGeneron’s actively enrolling clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.
InGeneron is a clinical-stage biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to validate our technology as a disease-modifying treatment. Based on more than 20 years of research, InGeneron is dedicated to developing therapies supported by clinical evidence and approved by the FDA.
Eckhard Alt, MD, PhD
Executive Chairman of InGeneron
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