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

NCT05711849 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Refractory Angina Pectoris
  • Refractory Angina

Interventions

BIOLOGICAL

Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.

Bone marrow will be harvested from the posterior superior iliac crest under local anaesthetic, and mononuclear cells will be separated using a Ficoll technique in a certified laboratory. Later that same day, the participant will undergo an intracoronary cell infusion of the mononuclear cells. Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and cell infusion).

PROCEDURE

Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).

These participants will have a sham bone marrow aspiration (a 3mm incision in the skin under local anaesthetic) and a sham intracoronary infusion procedure (the insertion of radial or femoral sheath under local anaesthetic). Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the sham bone marrow aspiration and sham cell infusion).

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Anthony Mathur · Barts & The London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United Kingdom

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 NCT05711849 on ClinicalTrials.gov