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

NCT04057833 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 1 other identifier: 2018-0809
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Short-term safety

  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).

  0 surgery to +11 days post op

Secondary Outcomes (4)

• Long-term safety

  post-operative 90 day to 1 year following the surgical repair

• MRI

  post-operative 90 day to 1 year

• Strength

  post-operative 90 day to 1 year

• PROMS

  post-operative 90 day to 1 year

Study Arms (1)

E-CEL UVEC

EXPERIMENTAL

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

Interventions

E-CEL UVEC DRUG

Local implantation of E-CEL UVEC cells at the supraspinatus tendon repair site

E-CEL UVEC

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Angiocrine Bioscience: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Rotator Cuff Injuries; Muscular Atrophy; Asthenia

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Scott Rodeo, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 15, 2019
• Study Start: November 20, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)