dm+d

Unassigned

New Medicines

Microvascular angina or coronary microvascular dysfunction (CMD)

Information

New molecular entity
Caladrius
Caladrius

Development and Regulatory status

None
None
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].

Category

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)
Intracoronary

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].