drugset / Trial / NCT03145298

ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy

NCT03145298 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure. Even with substantial pharmacologic advances in the modern treatment era, survival still remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest that the administration of allogeneic CDCs have the potential to reduce adverse arteriolar remodeling in PAH which was the basis for the approved investigational new drug (IND). The use of CDCs as an adjunctive therapy in patients comprising 4 sub-groups of patients with PAH in which inflammation and immune dysfunction are key pathophysiologic drivers of PAH.

Timeline

Start
2017-10-01
Primary completion
2023-01-31
Completion
2023-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic Human Cardiosphere-Derived Stem Cells Cell therapy 5e+07 cells —
Subject Allogeneic Human Cardiosphere-Derived Stem Cells Cell therapy 1e+08 cells —