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

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT04057833
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Muscle Atrophy or Weakness
  • Rotator Cuff Tears
  • Safety Issues
  • Tendon Rupture - Shoulder

Eligibility Criteria

Sex
ALL
Age
45 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 20, 2019
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Short-term safety [ Time Frame: 0 surgery to +11 days post op ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021-

Find similar trials in New York, NY

By research site
Hospital for Special Surgery· New York, NY

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