First Study Testing Cell Therapy for Rotator Cuff Surgery Launches at HSS
Scott A. Rodeo, MD, a sports medicine surgeon and clinician-scientist at Hospital for Special Surgery (HSS) has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery.
The rotator cuff is a collection of muscles and tendons at the shoulder joint that allows it to move. Overuse from repetitive overhead activities like swimming, tennis, or pitching a baseball, or acute injuries, can cause tears in the muscles or tendons of the rotator cuff.
“Arthroscopic shoulder surgery for rotator cuff tears is effective for relieving pain, restoring function and improving quality of life, but up to 25% of patients show incomplete or failed healing on imaging,” says Dr. Rodeo. “The frequency of incomplete or failed healing is more pronounced in patients over the age of 60. That matters because more people today want to stay active as they age.”
Many tissues in the body, including muscles and tendons, harbor stem cells that have the ability to form new tissues. The new clinical trial will test whether injecting an experimental cell therapy into both the muscle and the tendon of an injured rotator cuff will stimulate stem cell activity and promote better repair.
The engineered cell therapy product is E-CEL UVEC®, produced by San Diego based Angiocrine Bioscience, Inc. The investigational product consists of endothelial cells derived from the walls of the blood vessels of human umbilical cords that have been genetically modified to maintain their stability and their regenerative properties. The US Food and Drug Administration has granted the cell therapy Investigational New Drug (IND) status.
In a previous basic science study led by Dr. Rodeo, the cell therapy showed accelerated healing and an increase in the strength of the tendon attachment at the repair site, with no observable side effects, compared to surgery alone.
In the new clinical trial, patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair will receive two injections of the cell therapy: one into the tendon and one into the adjacent muscle. The study is open-label, meaning that all volunteers will know that they received the cell therapy.
The primary objective of the trial is to evaluate the safety of the cell therapy over 12 months. Dr. Rodeo and his research team will use blood tests to check whether the experimental cells have migrated away from the rotator cuff repair site. The investigators will also evaluate patients’ symptoms as well as shoulder strength, motion and healing as measured by MRI, ultrasound and patients’ reports about their progress.
“Improving patients’ symptoms with standard rotator cuff surgery is good, but strength improvements are less predictable,” Dr. Rodeo says. “Identification of new ways to improve healing and muscle function would represent a significant advance in the treatment of rotator cuff tendon tears.”
“We continue to enjoy working with Dr. Rodeo and his team on this long-term collaborative effort and look forward to providing support for this exciting new therapeutic application of E-CEL UVEC cells,” commented Paul Finnegan, MD, Angiocrine’s CEO.
The study opened September 1, 2019, with the goal of recruiting up to 20 patients ages 45 to 70 with full-thickness rotator cuff tears confirmed by physical examination and MRI. Eligible participants must already have tried and failed standard non-operative approaches, including a minimum of three months of physical therapy, oral anti-inflammatory medications, or a steroid injection.
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 11th consecutive year), No. 4 in rheumatology by U.S. News & World Report (2020-2021), and named a leader in pediatric orthopedics by U.S. News & World Report “Best Children’s Hospitals” list (2020-2021). HSS is ranked world #1 in orthopedics by Newsweek (2020-2021). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 130 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.