REGENERATE-COBRA: A phase II randomized sham-controlled trial assessing the safety and efficacy of intracoronary administration of autologous bone marrow-derived cells in patients with refractory angina
Study context
- Population
- Refractory angina patients with no revascularization options, symptomatic despite optimal medical and device therapyplanned enrolment
- Participants
- 110 patients
- Planned comparison
- Intracoronary autologous bone marrow-derived mononuclear cells vs sham procedure
- Primary endpoint
- Improvement in Canadian Cardiovascular Society (CCS) angina class by 2 classes
- Follow-up
- Between baseline and 6 months
Methodological detailsdesign/protocol, single site, blinded, sham-controlled, Phase II
- Design/protocol
- Single site
- Blinded
- Sham-controlled
- Phase II
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
REGENERATE-COBRA: A phase II randomized sham-controlled trial assessing the safety and efficacy of intracoronary administration of autologous bone marrow-derived cells in patients with refractory angina. Am Heart J. Published 9 June 2024. doi:10.
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