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

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 tasks and has negative impacts on qualify-of-life. The frequency of failed healing and re-tear following repair is more pronounced in patients over age 60 due to age-related, intrinsic degenerative changes involving the muscle, tendon, and enthesis.

Healing of the enthesis, the site of tendon attachment to the bone, can be compromised due to microvascular and vascular niche deficiencies resulti...

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