CIRM Funded Clinical Trials

Pulmonary Arterial Hypertension Treated with Cardiosphere-Derived Allogeneic Stem Cells


Disease Area:
Pulmonary Hypertension, Vascular Disease
Investigator:
CIRM Grant:
CLIN2-09444 (Closed)
Award Value:
$7,354,772.00
Trial Stage:
Phase 1/2
Trial Status:
Completed
Targeted Enrollment:
26
ClinicalTrials.gov ID:

Details:

Pulmonary arterial hypertension (PAH) is a progressive condition with no cure. Scientists at Cedars-Sinai Medical Center are using donor cells derived from the heart to reduce two hallmark symptoms of pulmonary hypertension: inflammation and high blood pressure in the blood vessels within the lungs. These conditions make the heart struggle to pump blood to the heart and lungs, and over time, can ultimately lead to heart failure. The aim of this treatment is to delay the progression of the disease.

Design:

Phase 1a: dose escalation, safety. Phase 1b: randomized, placebo-controlled safety/efficacy. Single dose, central intravenous infusion.

Goal:

Primary: Safety. Secondary: Exploratory efficacy measures of right ventricular function.

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