A Phase 1 Open-Label, Single-Center Investigator Initiated Trial (IIT) of E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

2018-0809

This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.

2019-11-20

2024-10-01

2024-10-01

Active (not recruiting)

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-11-15