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Angiogenic Cell Therapy

Angiogenic Cell Therapy for Pulmonary Hypertension (SAPPHIRE Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Northern Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
WHO functional class II, III, or IV on stable therapy for PAH for at least 3 months
Age ≥ 18 years, ≤ 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 9 months
Awards & highlights

SAPPHIRE Trial Summary

This trial is testing whether a treatment involving a person's own cells, transfected with human eNOS, is effective and safe for patients with severe PAH who are already on other PAH-targeted therapies.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, immune responses to modified cells, or complications from underlying health issues exacerbated by treatment.

SAPPHIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PAH is classified as moderate to severe, and I've been on stable treatment for over 3 months.
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I am between 18 and 80 years old.
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I can walk between 125 and 440 meters in 6 minutes.
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My condition is scleroderma with associated pulmonary arterial hypertension.
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I have not used appetite suppressants or been exposed to toxins.
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My PAH is caused by genetics, scleroderma, drugs/toxins, or heart defects.
Select...
My tests show I don't have blood clots in my lungs.
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I am between 18 and 80 years old.
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I can walk by myself, even if I use oxygen.
Select...
My pulmonary arterial hypertension is either idiopathic or inherited.

SAPPHIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in 6 Minute Walk Distance (6MWD) from Baseline
Change in Echocardiography Right Ventricular (RV) Function Measures from Baseline
Change in Magnetic Resonance Imaging Right Ventricular (RV) Function Measures from Baseline
+3 more

SAPPHIRE Trial Design

3Treatment groups
Experimental Treatment
Group I: Placebo followed by Autologous EPCs transfected with eNOSExperimental Treatment1 Intervention
4 monthly IV injections of Placebo (Plasma-Lyte A) during Course 1 followed by 4 monthly IV injections of Autologous EPCs transfected with human eNOS (total of 80 million cells) during Course 2
Group II: Autologous EPCs transfected with eNOS followed by PlaceboExperimental Treatment1 Intervention
4 monthly IV injections of Autologous EPCs transfected with human eNOS (total of 80 million cells) during Course 1 followed by 4 monthly IV injections of Placebo (Plasma-Lyte A) during Course 2
Group III: Autologous EPCs transfected with eNOSExperimental Treatment1 Intervention
4 monthly IV injections of Autologous EPCs transfected with human eNOS in Course 1 followed by 4 monthly injections of Autologous EPCs transfected with human eNOS in Course 2 (total of 160 million cells)

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteOTHER
559 Previous Clinical Trials
2,785,540 Total Patients Enrolled
Northern TherapeuticsLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Autologous EPCs transfected with human eNOS (Angiogenic Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03001414 — Phase 2 & 3
Pulmonary Hypertension Research Study Groups: Autologous EPCs transfected with eNOS followed by Placebo, Autologous EPCs transfected with eNOS, Placebo followed by Autologous EPCs transfected with eNOS
Pulmonary Hypertension Clinical Trial 2023: Autologous EPCs transfected with human eNOS Highlights & Side Effects. Trial Name: NCT03001414 — Phase 2 & 3
Autologous EPCs transfected with human eNOS (Angiogenic Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03001414 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to sign people up for this experiment?

"The clinicaltrials.gov website indicates that this trial is currently recruiting patients. The original posting date was September 28, 2017, and the most recent edit was made on April 27, 2022."

Answered by AI

How many people will be given lenalidomide in this experiment?

"The sponsor, Northern Therapeutics, needs to enroll 45 patients that meet the study's inclusion criteria. The trial will take place in various locations including Toronto General Hospital in Toronto, British Columbia and Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval in Quebec, Alberta."

Answered by AI

Are middle-aged adults welcome in this clinical trial?

"According to the information available, people between 18-80 years old who meet the other inclusion criteria can apply for this trial. There are 59 similar trials for minors and 706 for elderly patients."

Answered by AI

At how many research facilities is this project being overseen?

"To reduce participant burden, the 7 clinical trial sites for this study are located in or near major cities including Toronto, Quebec, and London. If you choose to participate in this research project, please select the site closest to your home to minimize travel requirements."

Answered by AI

Could I be a test subject for this experiment?

"This trial is looking for 45 participants that have hypertension and pulmonary. The patients must also meet the following requirements: An average 6-Minute Walk Distance (6MWD) of ≥ 125 meters and ≤ 440 meters on two consecutive tests during the Screening period, Age ≥ 18 years, ≤ 80 years, Idiopathic or heritable PAH;, Scleroderma associated PAH (limited or diffuse);, Drugs (anorexigens) or toxins;, Congenital heart defects (atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired ≥"

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Mar 2025