New Medicines

Microvascular angina or coronary microvascular dysfunction (CMD)


New molecular entity

Development and Regulatory status

Phase II Clinical Trials
Nov 20Caldrius expects to initiate the next CMD trial, a PIIb study, by Dec 20 [4].
Aug 19Caladrius Biosciences, after close collaboration with the US FDA, finalises the PIII trial protocol design. It intends to initiate enrolment in the trial in early 2020 [3].
Aug 18US FDA grants regenerative medicine advanced therapy (RMAT) designation to CLBS14 (CLBS16) for treatment of refractory angina [3].


CD34+ cell therapy
The prevalence of microvascular angina is estimated to be up to 30% of stable angina patients with non-obstructive coronary arteries. 19% of women presenting with acute coronary syndrome, 30% of women presenting with unstable angina, 9.1% of women with non-ST-elevation myocardial infarction and 10% of women with ST-elevation myocardial infarction were determined to have normal or non-obstructive coronary arteries using coronary angiography [1].
Microvascular angina or coronary microvascular dysfunction (CMD)

Trial or other data

Oct 20PII FREEDOM study to explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease starts (NCT04614467). 105 eligible adults will receive a single administration of CLBS16 or placebo, recruited at The Christ Hospital in Ohio, US (no UK trial sites). Primary outcomes are change from baseline in peak coronary flow reserve to 6 months, change from baseline in angina frequency to 3 and 6 months, change from baseline in total exercise time to 6 months, and change from baseline in health-related quality of life (HRQoL) to 3 and 6 month. Collection of these data is due to complete Apr 22 [5].
Nov 19The ESCaPE-CMD1 trial is an interventional, proof-of-concept study designed to evaluate the effect CD34+ cell therapy (CLBS16) on CMD symptoms and indicators. The key endpoint was measurement of the change from baseline of coronary flow reserve, a direct measure of microvascular function, at six months following a single injection of CLBS16. The trial completed enrollment of the targeted 20 patients in May of 2019. Investigators observed a highly statistically significant (p=0.0087) increase in coronary flow reserve after a single intracoronary administration [2].