22 Participants Needed

Angiogenic Cell Therapy for Pulmonary Hypertension

(SAPPHIRE Trial)

Recruiting at 6 trial locations
DJ
KD
Overseen ByKim Danovitch, CCRP
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Northern Therapeutics
Must be taking: PAH-targeted therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

DJ

Duncan J Stewart, MD FRCPC

Principal Investigator

Northern Therapeutics, Inc.

Are You a Good Fit for This Trial?

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

My PAH is classified as moderate to severe, and I've been on stable treatment for over 3 months.
I had surgery to fix a heart defect more than a year ago.
I can walk between 125 and 440 meters in 6 minutes.
See 14 more

Exclusion Criteria

I do not have a disease that severely limits my ability to walk.
You have three or more specific risk factors for heart failure with preserved ejection fraction (HFpEF) mentioned in the AMBITION study.
Unable to provide informed consent and comply with the visit schedule
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Apheresis and Randomization

Participants undergo apheresis for cell collection and are randomized to treatment arms

1 week
1 visit (in-person)

Treatment Course 1

Participants receive 4 monthly IV infusions according to their assigned treatment arm

6 months
4 visits (in-person)

Treatment Course 2

Participants receive another 4 monthly IV infusions according to their assigned treatment arm

6 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
11 visits (in-person)

Long-term Registry

Participants are followed for long-term safety information through annual telephone contacts

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous EPCs transfected with human eNOS
Trial Overview The SAPPHIRE trial is testing the safety and effectiveness of monthly doses of autologous EPCs enhanced with human eNOS gene against a placebo in improving symptoms of PAH. Participants will receive either the treatment first followed by placebo or vice versa.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Placebo followed by Autologous EPCs transfected with eNOSExperimental Treatment1 Intervention
Group II: Autologous EPCs transfected with eNOS followed by PlaceboExperimental Treatment1 Intervention
Group III: Autologous EPCs transfected with eNOSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northern Therapeutics

Lead Sponsor

Trials
3
Recruited
40+

Ottawa Hospital Research Institute

Collaborator

Trials
585
Recruited
3,283,000+
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