Clinical trial NCT04057833: E-CEL UVEC Cells As an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Rotator Cuff Tears
Muscle Atrophy or Weakness
Tendon Rupture - Shoulder
Safety Issues
Keywords: Cell Therapy
Supraspinatus tendon
Systemic safety and toxicity
Muscle and Tendon quality
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Angiocrine Bioscience
First posted: 2019-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Short-term safety
timeFrame: 0 surgery to +11 days post op
Secondary outcomes:
measure: Long-term safety
timeFrame: post-operative 90 day to 1 year following the surgical repair
measure: MRI
timeFrame: post-operative 90 day to 1 year
measure: Strength
timeFrame: post-operative 90 day to 1 year
measure: PROMS
timeFrame: post-operative 90 day to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Scott Rodeo, MD
role: PRINCIPAL_INVESTIGATOR
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