Phase II Randomized Trial of Intracoronary Autologous Bone Marrow Stem Cells for Treating Refractory Angina

What this Trial Is About

Researchers are evaluating whether using a patients own stem cells can improve angina symptoms and quality of life for people with refractory angina, a condition where chest pain persists despite standard treatments. This phase II, randomised, double-blind clinical trial compares the effects of intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment. The study involves 110 symptomatic patients and aims to assess changes in angina severity and other health outcomes. Participants are randomly assigned to either the treatment group, which receives bone marrow aspiration from the hip followed by infusion of stem cells into the hearts arteries, or the sham group, which undergoes similar procedures without actual stem cell collection or infusion. Both groups experience local anaesthetic procedures with measures to maintain blinding, such as wearing blindfolds and noise-cancelling headphones. Follow-up includes phone calls at 1 and 12 months and a clinic visit at 6 months. During the study, patients will have evaluations of their angina symptoms using the Canadian Cardiovascular Society score, quality of life assessments, exercise tolerance tests, and imaging to measure heart blood flow. Safety is monitored through adverse event tracking and major cardiovascular event assessments. The main outcome measure is the change in angina score from baseline to 6 months after treatment. The total participation duration includes these follow-up points, ensuring careful monitoring of treatment effects and safety.

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