Muscle Atrophy or Weakness, Rotator Cuff Tears, Safety Issues, Tendon Rupture - Shoulder
Conditions
Keywords
Cell Therapy, Supraspinatus tendon, Systemic safety and toxicity, Muscle and Tendon quality
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 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.
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 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 resulting from various causes including aging, prior injuries, and/or tissue degeneration. There is currently no approved adjunct biologic therapy to improve surgical repairs of full rotator cuff tear, enhance post-operative recovery, and decrease the risk of re-tear. This trial will investigate the safety and feasibility of local implantation of E-CEL UVEC cells along with standard-of-care arthroscopic surgical repair of full rotator cuff tears. E-CEL UVEC cells are proprietary allogeneic human umbilical vein endothelial cells produced under cGMP and cGTP regulations.
Interventions
DRUGE-CEL UVEC
Local implantation of E-CEL UVEC cells at the supraspinatus tendon repair site
Sponsors
Hospital for Special Surgery, New York
Angiocrine Bioscience
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term safety | 0 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety | post-operative 90 day to 1 year following the surgical repair | The primary study outcomes are measures of local and systemic safety and toxicity via symptom reporting (post-operative day +90 to 1 year post-op). Symptom reporting will evaluate pain and swelling based on a 0 to 100mm visual analog scale range, in addition to further symptom reporting. |
| MRI | post-operative 90 day to 1 year | Re-tear rate based on clinical and MRI evaluation for MRI assessments of muscle and tendon quality, measured as a percentage of total volume (%). |
| Strength | post-operative 90 day to 1 year | Shoulder strength during regular intervals post-operatively up to 1 year. BioDex system 3 will measure Peak Toque in Nm, scapular plane abduction strength 0-90 degrees. |
| PROMS | post-operative 90 day to 1 year | Patient-reported outcomes post-operatively up to 1 year. ASES affected vs unaffected shoulder score (each test has a maximum score of 100 points). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott Rodeo, MD
Hospital for Special Surgery, New York
Outcome results
None listed