Dr C. Noel Bairey Merz Discusses ESCaPE-CMD Phase 2 Study Results of Patients With CMD
The phase 2 ESCaPE-CMD study results exhibited a significant improvement in coronary flow reserve for patients with CMD, said C. Noel Bairey Merz, MD, FACC, FAHA, director of the Barbra Streisand Women's Heart Center.
Transcript Can you describe the primary endpoint of the ESCaPE-CMD trial and how positive results were obtained through the CLBS16 treatment?
The trial name is actually ESCaPE-CMD coronary microvascular dysfunction. The primary outcome was invasively measured intracoronary adenosine coronary flow reserve, a rigorous method which we have demonstrated previously as quite reproducible without change in other placebo control trials. What the outcome demonstrated in this trial was an amine score for the group of 20 subjects of 2.0. So, very abnormal coronary flow reserve in these microvascular angina patients improved to a mean of 2.6, a very significant improvement and much better than what we have achieved with other placebo-controlled trials such as ACE inhibitors or high intensity statins.
What impact has CD34 cell therapy had on microvascular function for patients with CMD?
We found in this phase 1, 2 pilot trial of 20 subjects, open label, that the CD34 cells had a quite dramatic effect on invasively measured coronary flow reserve. The average was 2–went up to 2.6, meaning the average patient normalized, and that this was permanent or persistent through a 6-month follow up. A number of patients became angina free.
What do the study results presented at AHA 2019 reveal about the impact of CLBS16 on CMD?
Based on the clinical coronary flow reserve data, these suggest that this will be an effective therapy for coronary microvascular dysfunction patients. Needless to say, this was open label, so we cannot discount a placebo effect–perhaps in the Seattle Angina Questionnaire scores; but the rigor of an objectively measured coronary flow reserve, which we’ve demonstrated previously changes very little with a placebo in other trials that we’ve done, suggest that this may be a beneficial therapy which requires further definitive testing.