FDA-Approved Randomized Controlled Feasibility Study Finds InGeneron’s Regenerative Cell Therapy to Significantly Reduce Pain and Improve Shoulder Function Over Corticosteroid Injection to Address Symptomatic Partial-Thickness Rotator Cuff Tears
InGeneron announces publication of favorable results using regenerative cells isolated from patients’ own body fat prepared with the Transpose® RT System in the Journal of Orthopaedic Surgery and Research.
Houston, TX, April 7, 2020 – Results of a U.S. FDA-approved, randomized controlled feasibility study on treatment of symptomatic partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) are now available in the Journal of Orthopaedic Surgery and Research.
This prospective multicenter feasibility study performed by Sanford Health is the first randomized controlled trial in which cells isolated from patients’ own adipose tissue were compared to another therapy option for treating sPTRCT. Specifically, subacromial injection of corticosteroid was compared to injection of UA-ADRCs isolated from the subjects’ own adipose tissue using InGeneron’s Transpose® RT System. Assessment at 24 and 52 weeks post-treatment demonstrated significantly higher mean American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) total scores (indicating reduced pain and improved shoulder function) of the subjects in the UA-ADRC group compared to the subjects in the corticosteroid group at both time points. Additionally, there were no significant complications or adverse events associated with the injection of UA-ADRCs during a period of twelve months post-treatment, with 20% of the subjects in the corticosteroid group experiencing full-thickness rotator cuff tears during the same period post-treatment.
Based on the positive outcome of this feasibility study, InGeneron is currently enrolling a multi-centre (up to 20 sites), nationwide FDA IDE pivotal study involving a significantly larger number of patients than the feasibility study (ClinicalTrials.gov Identifier: NCT03752827).
Symptomatic partial-thickness rotator cuff tears (sPTRCT) are among the most common injuries and ailments of the shoulder, especially in elderly patients. Subacromial corticosteroid injection, one of the standard therapies for sPTRCT, often leads to a temporary improvement in clinical symptoms, but not a cure. Furthermore, repeated subacromial corticosteroid injections were reported to be detrimental to tendon healing.
“The study shows that unmodified, autologous ADRCs isolated from patients’ own adipose tissue at point-of-care using InGeneron’s Transpose® RT System represent a powerful and highly innovative alternative for treating symptomatic PTRCT,” said Dr. John Furia, a board-certified orthopaedic surgeon, who along with Dr. Nicola Maffulli (London, UK) served as clinical and scientific advisors. “Injection of ADRCs into diseased tendons has the potential to jump-start the human response. The science is catching up with the hype and I’m optimistic this modality will play an important role in how we treat our patients going forward.”
The complete results of the study, entitled “Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study“, (DOI: https://doi.org/10.1186/s13018-020-01631-8) were published in the Journal of Orthopaedic Surgery and Research on March 30, 2020.
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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