Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials

A combined patient-level analysis of three sequential double-blind clinical trials enrolling Class III and IV RA patients encompassing over a decade of enrollment demonstrated consistent and durable improvements in exercise capacity, AF, and mortality. These findings suggest that had RENEW been run to completion, a viable regenerative approach to the treatment of RA might have met criteria for clinical approval. These findings point to the promise and need for additional study of this therapy, and serve as a cautionary note of the potential loss to the medical and clinical/patient communities of the premature termination of clinical studies. Given the significant unmet clinical need for these no option patients, approaches to more rapid and cost efficient appraisal of such therapies are needed.

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