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

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv14
  2. Primary and study completion dates: Oct 2025 to Oct 2026v13
  3. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Oct 2024 to Oct 2025
    v12
  4. Primary and study completion dates: Oct 2023 to Oct 2024v11
  5. Primary completion date: Jan 26, 2023 to Oct 2023
    • Study completion date: Mar 26, 2023 to Oct 2023
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv9 Show 4 more changesShow less
    • Enrollment target: estimated 15 to confirmed 20
    • Primary completion date: Feb 26, 2023 to Jan 26, 2023
    • Study completion date: Jul 26, 2023 to Mar 26, 2023
    • Site details revised
  2. Primary completion date: Feb 26, 2022 to Feb 26, 2023
    • Study completion date: Jul 26, 2022 to Jul 26, 2023
    v8
  3. Primary completion date: Feb 26, 2021 to Feb 26, 2022
    • Study completion date: Jul 26, 2021 to Jul 26, 2022
    • Study description shortened, about 231 words
    v7
  4. Primary completion date: Nov 26, 2020 to Feb 26, 2021
    • Study completion date: Nov 26, 2020 to Jul 26, 2021
    v6
  5. Primary completion date: Jul 31, 2020 to Nov 26, 2020
    • Study completion date: Oct 1, 2020 to Nov 26, 2020
    • Start date changed from estimate of Nov 1, 2019 to Nov 20, 2019
    v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  7. Start date: Sep 1, 2019 to Nov 1, 2019v3
  8. Collaborator revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04057833
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: Angiocrine Bioscience
Conditions
(from sponsor)		 Rotator Cuff Tears, Muscle Atrophy or Weakness, Tendon Rupture - Shoulder, Safety Issues
Related terms Asthenia, Muscular Atrophy, Rotator Cuff Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov