Randomized controlled trial meets primary endpoint and finds statistically significant durable patient benefit 3.4 years post-treatment.
Houston, TX, USA, November 13, 2023 – InGeneron, Inc., a clinical-stage biotechnology company, today announced positive clinical trial data demonstrating long-term safety and efficacy of InGeneron’s cell therapy for treating partial-thickness rotator cuff tears. The results of InGeneron’s randomized, controlled study, which followed patients for 3.4 years after treatment, were published under the title “Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection of corticosteroid”, in Nature’s Scientific Reports on November 9th, 2023.
Symptomatic, partial-thickness rotator cuff tears (sPTRCT) are a common cause of shoulder pain, loss of function, and occupational disability. Current non-surgical and surgical treatments do not offer a natural replacement of damaged tendon tissue and often fail to improve clinical results. InGeneron’s therapy involves the use of adipose-derived regenerative cells (ADRCs), which may promote healing and tissue regeneration by reducing inflammation, inducing the formation of new blood vessels, and generating new tissue to augment damaged tissue.
Participants in the study were randomly assigned to receive either a single injection of ADRCs or a single injection of corticosteroid. This long-term follow-up study, conducted over 41 months (3.4 years) post-treatment, showed that ADRCs were not only safe, but also more effective than corticosteroid injections for improving shoulder function and reducing pain in the treated patients. These findings reinforce the previously published 1-year follow-up results and highlight the potential of InGeneron’s cell therapy to provide patients with lasting clinical benefits. Additionally, MRI scans of the patients taken at 6 months post-treatment gave further insight into how the ADRCs worked within the damaged tissue.
“The findings from this study further validate the promise of this regenerative cell therapy as a disease-modifying treatment for orthopedic conditions,” said InGeneron’s Executive Chairman Eckhard Alt, MD PhD. “I am excited about the long-term efficacy of the treatment indicated in this study and the prospect of offering a minimally invasive treatment option for many patients who do not find relief from the treatments available today. We believe these findings mark a significant milestone toward advancing the standard of care for partial-thickness rotator cuff tears by offering a durable, regenerative alternative to the traditional corticosteroid treatment pathway.”
Research efforts continue with ongoing clinical trials aimed at gathering comprehensive data to support future regulatory submissions. InGeneron’s Transpose RT® cell therapy system is currently being evaluated in three ongoing FDA-approved clinical trials for the treatment of partial-thickness rotator cuff tears, wrist osteoarthritis and facet joint syndrome.
Citation: Lundeen, M., Hurd, J.L., Hayes, M. et al. Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection of corticosteroid. Sci Rep 13, 19348 (2023).
About the Transpose® RT System and Current 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 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
+1 (713) 440 9900
Corporate Development and Strategy Manager