Company enrolls first patients in multi-center trial evaluating regenerative cell therapy at the point of care for partial rotator cuff tears
Houston, TX, USA, May 15, 2019 – InGeneron, Inc., a regenerative medicine and cell therapy company, announced today the enrollment of the first patients in a pivotal study evaluating InGeneron’s cell therapy as a way to treat partial thickness rotator cuff tears involving a partial tear in the supraspinatus tendon. The primary goal of the double-blinded, multi-center trial is to demonstrate the effectiveness of the company’s autologous point-of-care cell therapy in treating this indication. The U.S. Food and Drug Administration (FDA) has granted approval to begin the study, and patient enrollment has started. The trial plans to enroll 246 patients at up to 15 sites across the U.S. and is among the largest regenerative cell therapy studies in this indication to date.
A partial rotator cuff tear is one of the most common orthopedic impairments of a person’s shoulder, and can be characterized by a degenerative and often chronic condition found in the supraspinatus tendon. The condition is estimated to affect more than one million patients in developed economies annually. InGeneron is investigating the use of autologous adipose (fat)-derived regenerative cells (ADRCs) as an outpatient treatment to potentially provide patients with better options than currently available.
InGeneron’s therapeutic approach involves isolating regenerative cells from patients’ own adipose tissue through a minimally invasive liposuction procedure, processing them with the company’s proprietary technology, and injecting the isolated cells in the site of the patient’s injury under ultrasound guidance. The pivotal study is double-blinded and will include a group of patients who receive the cell therapy treatment and a control group that receives a corticosteroid injection. The use of corticosteroids is a current standard of care in the treatment of partial rotator cuff tears. Patients enrolled in the study will be monitored through follow-up visits for 48 weeks following the intervention. More information about the study is available on www.clinicaltrials.gov
The company’s pivotal trial for rotator cuff tendinopathy represents its clinical lead program and builds on positive outcomes of a previous feasibility study reported in December 2018, which found InGeneron’s therapy for rotator cuff tears to be safe and well-tolerated. While these results are being prepared for peer-reviewed publication, top-line data of the trial can be found on the company’s website.
“Following the positive results of our feasibility study, the enrollment of the first patients in this pivotal program is another important milestone on our way toward introducing regenerative cell therapy to clinical practice,” said Angelo Moesslang, PhD, Chief Executive Officer of InGeneron. “We look forward to further generating evidence of the safety and clinical benefit of our therapeutic approach, and are optimistic that the trial will support our efforts to obtain a label approval to market our technology for this indication in the U.S.”
Focusing its development activities on orthopedic indications, InGeneron has two additional clinical programs in place. Earlier this year, the first patients were enrolled in feasibility studies for facet joint syndrome, one of the major causes of chronic back pain, and wrist osteoarthritis, a condition resulting in diminished grip strength and a limited range of motion in the wrist.
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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