Recruitment is underway for a study that will evaluate whether injecting stem cells derived from adipose tissue in a patient’s abdomen can improve healing and shoulder function following rotator cuff surgery.
“Rotator cuff tendon tears are among the most frequent and debilitating upper extremity injuries, with more than 4 million physician office visits and a quarter of a million surgical repairs in the US annually,” said Scott Rodeo, MD, principal investigator and director of the Center for Regenerative Medicine at the Hospital for Special Surgery (HSS) Research Institute.
“Patients with chronic rotator cuff tears often have substantial muscle atrophy. Surgical repair of the tear does not reverse the atrophy, so a number of patients continue to experience weakness and reduced function, affecting their quality of life
“Our clinical trial will be the first to determine if stem cell therapy from adipose tissue can improve outcomes for patients having rotator cuff surgery,” said Dr. Rodeo, an orthopedic surgeon specializing in sports medicine at HSS.
Improving Tissue Regeneration
Numerous laboratory studies have evaluated the potential for these adipose-derived cells, known as stromal vascular fraction cells or SVFC, to enhance the repair and regeneration of orthopedic tissues. “Studies have shown that the therapeutic use of these cells improved tissue regeneration in a variety of acute and chronic musculoskeletal injury and disease models,” Dr. Rodeo said.
The current HSS study is a prospective, randomized, placebo-controlled trial that will include patients undergoing arthroscopic rotator cuff repair. To obtain the stem cells, the patient will have a type of liposuction procedure that takes 10 to 15 minutes. The cells will be extracted from the fat tissue with a centrifuge and administered to the patient’s rotator cuff muscle and tendon in the operating room right after surgery is completed.
Study participants will be followed for 2 years after the procedure and evaluated with:
- Imaging tests, including MRI and ultrasound
- Strength and range-of-motion measurements
- Patient-reported outcome scores
Informing Clinical Practice
Dr. Rodeo and colleagues hypothesize that patients who receive the stem cell treatment during surgery will experience enhanced tissue healing, as well as improved shoulder strength and function.
“We believe the results of this study will provide information that can guide the clinical use of cell-based approaches to augment tendon healing in the rotator cuff and potentially in other areas as well, such as the Achilles tendon,” Dr. Rodeo said.
“We will also gain information about the relationship between the biologic activity of the implanted cells and how this affects various clinical outcome parameters, including symptoms, strength, and structural healing.”
The study, supported by an $800,000 grant from the Orthopaedic Research and Education Foundation and the National Stem Cell Foundation, seeks to recruit a total of 56 participants.
Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears, ClinicalTrials.gov identifier (NCT number): NCT03332238. Available at https://clinicaltrials.gov/ct2/show/NCT03332238. Accessed April 6, 2022.