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Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina

Study acronym: RegenCobra
StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated January 7, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study completion date: Feb 28, 2026 to Aug 31, 2026
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2023 to Mar 1, 2024
    • Site details revised
    v4
  4. Interventions: Bone marrow aspiration and intracoronary infusion of autologous bone marrow-derived cells (Biological), Sham bone marrow aspiration and… to Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. (Biological), Sham bone…
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study description shortened, about 332 words
    • Site contact updated
    v3
  5. Start date: Apr 1, 2023 to Sep 1, 2023
    • Primary completion date: Mar 31, 2025 to Aug 31, 2025
    • Study completion date: Sep 30, 2025 to Feb 28, 2026
    • Secondary endpoints: details revised at 4 of 8 entries
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in. In the 'treatment' group: * Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration). * Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin. * The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months. In the 'sham' group: * A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic. * A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic. * The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.
Trial Details
NCT Number NCT05711849
Lead Sponsor Barts & The London NHS Trust
Conditions
(from sponsor)		 Refractory Angina Pectoris, Refractory Angina
Related terms Angina Pectoris
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov