InGeneron reports favorable results using regenerative cells isolated from patients’ own body fat and prepared with the Transpose® RT System for the treatment of symptomatic partial-thickness rotator cuff tears (sPTRCT).
The FDA-approved, prospective, multicenter, randomized controlled feasibility study 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. Assessment at 24 and 52 weeks demonstrated significantly higher mean ASES total scores (indicating reduced pain and improved shoulder function) of the subjects in the group receiving autologous adipose-derived regenerative cells (UA-ADRCs).
There were no significant complications or adverse events associated with the injection of UA-ADRCs during 12 months, while 20% of the corticosteroid subjects experienced full-thickness rotator cuff tears during the same period post treatment.
Based on the positive outcome, InGeneron is now enrolling a 20-site U.S. FDA Investigational Device Exemption pivotal study involving a significantly larger number of patients than the feasibility study.
InGeneron's Transpose RT System comprises a processing unit, a set of disposables and the Matrase™ enzyme mixture that enables the isolation of regenerative cells.
The system allows isolation of UA-ADRCs from patients' own adipose tissue at point of care within one hour. UA-ADRCs are administered into the defect by injection under ultrasound guidance. Other enrolling trials are evaluating use of the Transpose RT System to treat wrist osteoarthritis (OA) and OA of the facet joint in the lumbar spine.