The Hospital for Special Surgery has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery.
Scott A. Rodeo, M.D., a sports medicine surgeon and clinician/scientist at Hospital for Special Surgery (HSS), has launched a 20-patient open-label clinical trial of E-CEL UVEC®, an experimental engineered cell therapy under development to promote healing of rotator cuff tears after surgery.
E-CEL UVEC is produced by Angiocrine Bioscience. The investigational product comprises endothelial cells derived from human umbilical cords that have been genetically modified to maintain stability and regenerative properties. FDA has granted the therapy an Investigational New Drug status.
In a previous basic science study led by Dr. Rodeo, the therapy showed accelerated healing and an increase in the strength of the tendon attachment at the repair site, with no observable side effects, vs. surgery alone.
In the new trial, patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair will receive two injections of E-CEL: one in the tendon and one into the adjacent muscle. The primary objective is evaluation of safety of the cell therapy over 12 months, looking at symptoms as well as shoulder strength, motion and healing.
Eligible participants must already have failed standard non-operative approaches, including a minimum of three months of physical therapy, oral anti-inflammatory medications or a steroid injection.
Source: Hospital for Special Surgery