110
Participants
Start Date
March 1, 2024
Primary Completion Date
August 31, 2025
Study Completion Date
February 28, 2026
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).
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).
RECRUITING
St Bartholomew's Hospital, London
Barts & The London NHS Trust
OTHER