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Bairey Merz: ESCaPE-CMD Trial of CLBS16 Cell Therapy Shows Promise as Treatment for Coronary Microvascular Dysfunction


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.  

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