Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension

Summary

The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic severe PAH on available PAH-targeted medical therapy.

Timeline

Start

2017-09-28

Primary completion

2023-05-04

Completion

2023-11-01

Outcome

Missed primary endpoint

Stopped (Enrollment): “Lower than anticipated enrollment”

registry Arm 1 - Placebo During First 6 Months vs Arm 2 and 3 During First 6 Months; p = 0.42 NCT03001414 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Autologous EPCs Transfected with human eNOS	Unknown	8e+07 cells	Intravenous

Indications