Clinical Trial

Therapy for Progressive Pulmonary Hypertension

Study Description

Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Biological - Placebo followed by Autologous EPCs transfected with human eNOS

4 doses of placebo in first 6 months followed by 4 doses of autologous EPCs transfected with eNOS in second 6 months

Biological - Autologous EPCs transfected with human eNOS followed by Placebo

4 doses of autologous EPCs transfected with eNOS in first 6 months followed by 4 doses of placebo in second 6 months

Biological - Autologous EPCs transfected with human eNOS

4 doses of autologous EPCs transfected with eNOS in first 6 months which is repeated in second 6 months

Additional Information

Official Study Title

A Multicentre, Phase 2 Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments

Clinical Trial ID

NCT03001414

ParticipAid ID

PdynEe