Autologous CD34 Cell Therapy for Treatment of Coronary Microvascular Dysfunction in Patients With Angina and Non-Obstructive Coronary Arteries
Presenter
Timothy D. Henry, M.D., MSCAI, The Christ Hospital Health Network, Covington, KY
Timothy D. Henry, M.D., MSCAI1, Amir Lerman, M.D.2, Janet Wei, M.D.3, Michel T. Corban, M.D., FSCAI4, Sandy Joung3, Christine Kotynski, BS5, Michelle Lewis6, Ann Schumacher, MSN5, Vishal Shah6, Ronnda Bartel6, Jian Wang, MS5, William K Sietsema, Ph.D.7, Douglas W. Losordo, M.D., FACC, FAHA8 and C Noel Bairey Merz, M.D., FACC, FAHA9, (1)The Christ Hospital Health Network, Covington, KY, (2)Mayo Clinic Health System Rochester, Rochester, CT, (3)Cedars- Sinai Medical Center, Los Angeles, CA, (4)University of Arizona College of Medicine – Tucson, Tucson, AZ, (5)-, Rye Brook, NY, (6)Caladrius Biosciences, Rye Brook, NY, (7)Caladrius Biosciences, Basking Ridge, NY, (8)Caladrius Biosciences, Scarsdale, NY, (9)Barbara Streisand Women's Heart Center (Cedars Sinai), Los Angeles, CA
Keywords: Coronary, Stable Ischemic Heart Disease (SIHD) and Women's Health
Background:
Coronary microvascular dysfunction (CMD) results in ischemia, angina and adverse outcomes in patients with nonobstructive coronary artery disease (NOCAD), however no specific therapy exists. CD34+ cell therapy augments microvasculature in preclinical models and improves symptoms, exercise tolerance and mortality in refractory angina obstructive CAD pts.
Methods:
We conducted a 2-center NHLBI-sponsored (R44HL135889) trial of autologous CD34+ cell therapy (CLBS16-P01)(NCT03508609) in 20 NOCAD pts with persistent angina and invasive coronary flow reserve (CFR) ≤2.5. Measures included angina frequency, CCS Class, Seattle Angina Questionnaire (SAQ), modified Bruce exercise treadmill test (ETT), and labs. Subjects received GCSF 5mcg/kg/day for 5 days before leukapheresis, followed by manufacturing to enrich the CD34+ cell content. Cells were administered via a single infusion to the LAD coronary artery. 6-month assessment included invasive CFR, angina frequency, CCS, SAQ, and ETT.
Results:
Enrollment was completed May 2019 and final assessments December 2019. Table 1 shows demographics. CFR significantly increased from baseline to 6 months after a single infusion of CD34+ cells (p=0.0045). There were no cell-related adverse events. Angina frequency, CCS Class, SAQ scores and ETT will be presented.
Conclusions:
CD34+ cell therapy appears to be a promising therapy for CMD patients with angina and NOCAD. A prospective randomized clinical trial is being planned.
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