C. Noel Bairey Merz, MD, Director of the Barbra Streisand Women's Heart Center and Preventive and Rehabilitative Cardiac Center in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, was the lead investigator of a study of CLBS16 cell therapy for the treatment of coronary microvascular dysfunction (CMD), a condition that disproportionately afflicts women. Dr. Bairey Merz presented results from the ESCaPE-CMD trial at the 2019 American Heart Association Scientific Sessions.
The ESCaPE-CMD trial is an interventional, proof-of-concept study designed to evaluate the effect of an autologous CD34+ cell therapy (CLBS16, Caladrius Biosciences, Inc.) on CMD symptoms and indicators, while also evaluating treatment tolerance. 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. All patients received a single infusion of their own GCSF-mobilized CD34+ cells formulated as CLBS16. The trial completed enrollment of the targeted 20 patients in May of 2019.
Trial investigators observed that patients experienced a statistically significant increase in coronary flow reserve (CFR) at 6 months after a single intracoronary administration of CLBS16 (from 2.08 to 2.61, P=0.0087). The trial also evaluated changes from baseline to six months in chest pain frequency, Canadian Cardiovascular Society angina classification, and Seattle Angina Questionnaire scores. A single administration of CLBS16 resulted in statistically significant improvements in all these measures of patient symptoms and function.
The study’s three principal investigators are Dr. C. Noel Bairey Merz, Cedars-Sinai, Dr. Timothy D. Henry, The Christ Hospital, and Dr. Amir Lerman, Mayo Clinic.