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
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.
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-center (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 orthopedic 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 has developed the Transpose® RT System, which consists of a processing unit, a set of disposables and Matrase™, a unique enzyme mixture. The system allows isolation of UA-ADRCs from patients' own adipose tissue at point of care within approximately one hour. The UA-ADRCs are administered into the defect by injection under ultrasound guidance.
The Transpose® RT System is currently being investigated under FDA IDE approval and accessible for research use only in the US. Currently, InGeneron has several active, FDA approved clinical trials utilizing the Transpose® RT System that are enrolling. More information on these clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.
About InGeneron
InGeneron is a clinical stage cell therapy company enabling novel, safe and evidence-based regenerative medicine therapies. Our purpose is to set new therapeutic standards by developing treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day application. We focus on helping patients who are impacted by musculoskeletal indications and are pursuing research to extend the application of our platform technology to additional treatment areas.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200407005356/en/