E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
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|ClinicalTrials.gov Identifier: NCT04057833|
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : April 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tears Muscle Atrophy or Weakness Tendon Rupture - Shoulder Safety Issues||Drug: E-CEL UVEC||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 20, 2019|
|Estimated Primary Completion Date :||February 26, 2022|
|Estimated Study Completion Date :||July 26, 2022|
Experimental: E-CEL UVEC
Patients will receive an injection of the Cell therapy vehicle into their supraspinatus muscle and tendon at the time of rotator cuff repair.
E-CEL UVEC cells suspended in autologous plasma and combined with thrombin at the implantation site (tendon delivery).
E-CEL UVEC cells suspended in 6.0% Dextran 40 and 10.0% human serum albumin (HSA) (infusion solution) (muscle delivery).
Drug: E-CEL UVEC
Local implantation of E-CEL UVEC cells at the supraspinatus tendon repair site
- Short-term safety [ Time Frame: 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).
- Long-term safety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057833
|Contact: Camila Carballo, PhD||(212) firstname.lastname@example.org|
|Contact: Daniel Edon, MS||(212) email@example.com|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Danie Edon, MS, CSCS 212-774-7833 firstname.lastname@example.org|
|Principal Investigator:||Scott Rodeo, MD||Hospital for Special Surgery, New York|