E-CEL UVEC Cells As an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Aug 13, 2019

Keywords

ClinConnect Summary

This is an early-phase, single-arm clinical trial being done at Hospital for Special Surgery in New York. Researchers are testing whether adding E-CEL UVEC cells, a donor cell therapy, to the usual arthroscopic repair of a full-thickness rotator cuff tear is safe and feasible. The cells are placed at the tendon repair site during surgery and also into nearby muscle. All participants receive the cell therapy in addition to standard repair; there isn’t a comparison group or placebo in this study.

People who might be eligible are adults aged 45–70 with a confirmed one to three centimeter tear of the supraspinatus tendon that hasn’t improved after at least 3 months of non-surgical treatment, and with relatively preserved muscle health. Exclusions include tears of other shoulder tendons, significant arthritis, prior rotator cuff repair, certain medical conditions, pregnancy, and difficulty sticking to post-surgery rehab. The study will follow participants for up to about a year to check short-term and long-term safety, pain and swelling, shoulder strength, tendon and muscle healing on MRI, and patient-reported shoulder function. Enrollment is expected to be around 20 people, and results are not yet available; the trial started in 2019 and is anticipated to complete around October 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 45-70 years old
• • Diagnosis of full-thickness supraspinatus tendon tear by MRI and physical examination
• • Tendon retraction 1 to 3 cm on MRI
• • Goutallier score ≤ grade 2.
• • Failed standard non-operative treatments for tendon tear including a minimum of 3 months of physical therapy as well as oral anti-inflammatory medications, subacromial steroid injection, activity modification, etc.
• Exclusion Criteria:
• • Tears of any cuff tendon other than the supraspinatus
• • Frank signs of glenohumeral osteoarthritis on MRI
• • Diagnosis of acute tendon tear
• • Lack of significant pain and/or loss of function due to tendon tear History of previous rotator cuff repair
• • History of upper extremity fracture or other moderate to severe upper extremity trauma
• • BMI \< 20 or \> 35
• • Diagnosis of Type I or type II diabetes, or other metabolic disorders
• • Previous history of cancer. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible.
• • Diagnosis of an autoimmune disorder Know history of HIV
• • Current use of nicotine products
• • History of diabetes, malignancy within 5 years of the procedure, immunosuppression, autoimmune or connective tissue disorders such as lupus or rheumatoid arthritis, schizophrenia or other psychiatric disorder that could interfere with postoperative rehabilitation, or other disability that would obviously adversely impact the patient's ability to participate in standard postoperative rehabilitation
• • Pregnancy
• • Inability to comply with post-operative rehabilitation
• • Hypersensitivity reactions to bovine (cow) proteins