NCT04057833
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Enrolling by Invitation
PHASE1Ages 45–70InterventionalTreatmentHospital for Special Surgery, New YorkInvestigator-initiated
~20 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:E-CEL UVEC
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Short-term safety
Measured over 0 surgery to +11 days post op
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Scott Rodeo, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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
What this trial measures
- Short-term safety0 surgery to +11 days post op
The primary study outcomes are measures of local and systemic safety and toxicity via adverse event (AE) logs (post-operative day 0 to Day 11). AE are evaluated using a 5 point severity scale to grade the AE, 1 (mild) to 5 (death/ fatal).