Angiogenic Cell Therapy for Pulmonary Hypertension
(SAPPHIRE Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Duncan J Stewart, MD FRCPC
Principal Investigator
Northern Therapeutics, Inc.
Eligibility Criteria
Adults aged 18-80 with severe Pulmonary Arterial Hypertension (PAH) due to conditions like scleroderma or congenital heart defects, not participating in other trials or pulmonary rehab recently. Must be on stable PAH therapy for at least 3 months, able to walk unassisted, and meet specific criteria on diagnostic tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and Randomization
Participants undergo apheresis for cell collection and are randomized to treatment arms
Treatment Course 1
Participants receive 4 monthly IV infusions according to their assigned treatment arm
Treatment Course 2
Participants receive another 4 monthly IV infusions according to their assigned treatment arm
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Registry
Participants are followed for long-term safety information through annual telephone contacts
Treatment Details
Interventions
- Autologous EPCs transfected with human eNOS
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northern Therapeutics
Lead Sponsor
Ottawa Hospital Research Institute
Collaborator