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Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension

NCT03001414 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-01-31

Study results available
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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.

Conditions

  • Hypertension,Pulmonary

Interventions

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

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    collaborator OTHER

  • Northern Therapeutics

    lead INDUSTRY

Principal Investigators

  • Duncan J Stewart, MD FRCPC · Northern Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2023-05-04
Completion
2023-11-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001414 on ClinicalTrials.gov