Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057833
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Angiocrine Bioscience
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Muscle Atrophy or Weakness Tendon Rupture - Shoulder Safety Issues Drug: E-CEL UVEC Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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 (%).

  3. 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.

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Camila Carballo, PhD (212) 774-2028 carballoc@hss.edu
Contact: Daniel Edon, MS (212) 774-7833 edond@hss.edu

Locations
Layout table for location information
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Danie Edon, MS, CSCS    212-774-7833    edond@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Angiocrine Bioscience
Investigators
Layout table for investigator information
Principal Investigator: Scott Rodeo, MD Hospital for Special Surgery, New York
Publications:

Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04057833    
Other Study ID Numbers: 2018-0809
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital for Special Surgery, New York:
Cell Therapy
Supraspinatus tendon
Systemic safety and toxicity
Muscle and Tendon quality
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Atrophy
Atrophy
Rupture
Rotator Cuff Injuries
Pathological Conditions, Anatomical
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases