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

PHASE2RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

February 28, 2026

Conditions
Refractory Angina PectorisRefractory 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).

Trial Locations (1)

EC1A 7BE

RECRUITING

St Bartholomew's Hospital, London

All Listed Sponsors
lead

Barts & The London NHS Trust

OTHER