Status:
ENROLLING_BY_INVITATION
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Angiocrine Bioscience
Conditions:
Rotator Cuff Tears
Muscle Atrophy or Weakness
Eligibility:
All Genders
45-70 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Full-thickness rotator cuff tears present a clinical challenge, often with occurrence of re-tears after surgical repair and a slow rate of complete functional recovery, which limits daily functional t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04057833
Start Date
November 20 2019
End Date
October 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021