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

NCT04057833 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-26

No results posted yet for this study

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

Interventions

DRUG

E-CEL UVEC

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

Sponsors & Collaborators

  • Angiocrine Bioscience

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Scott Rodeo, MD · Hospital for Special Surgery, New York

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057833 on ClinicalTrials.gov