CLBS16

Unassigned

New Medicines

Microvascular angina

Information

Advanced therapy medicinal product (ATMP)
Caladrius
Caladrius

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Aug 19 · Caladrius 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 18 · US 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
Intracoronary

Trial or other data

Nov 19 · The 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]. 25/11/2019 16:23:33