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Angiogenic Cell Therapy for Pulmonary Hypertension (SAPPHIRE Trial)
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.
SAPPHIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAPPHIRE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SAPPHIRE Trial Design
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Who is running the clinical trial?
Media Library
- My PAH is classified as moderate to severe, and I've been on stable treatment for over 3 months.I am between 18 and 80 years old.I had surgery to fix a heart defect more than a year ago.I do not have a disease that severely limits my ability to walk.I can walk between 125 and 440 meters in 6 minutes.My condition is scleroderma with associated pulmonary arterial hypertension.You have three or more specific risk factors for heart failure with preserved ejection fraction (HFpEF) mentioned in the AMBITION study.You have participated in gene therapy or studies involving certain protein growth factors.I have not used appetite suppressants or been exposed to toxins.You are expected to live less than 1 year because of another health condition.I do not have any serious illnesses or abnormal lab results that could risk my safety or affect the study.My PAH is caused by genetics, scleroderma, drugs/toxins, or heart defects.Your blood pressure is too low.Your resting oxygen level is 88% or higher.My tests show I don't have blood clots in my lungs.I have a heart defect that hasn't been fixed or was recently repaired, except for a patent foramen ovale.I am between 18 and 80 years old.I have been on stable treatment for PAH for at least 3 months.I haven't used any experimental treatments in the last 3 months.My PAH is not caused by conditions listed in the trial's inclusion criteria.I have moderate to severe lung disease.My liver condition is severe.My kidney function is very low or I need dialysis.I have had a procedure to create a hole in the wall between the upper chambers of my heart.I have not had cancer in the last 5 years, except for a minor skin cancer that was fully treated.You are allergic to gentamicin or amphotericin.I can walk by myself, even if I use oxygen.A heart ultrasound shows specific things.You have had a specific heart test that showed signs of pulmonary arterial hypertension.I have a history of serious heart artery problems.You have a current infection with certain diseases during the screening process.You need to pass certain breathing tests.My pulmonary arterial hypertension is either idiopathic or inherited.
- Group 1: Autologous EPCs transfected with eNOS followed by Placebo
- Group 2: Autologous EPCs transfected with eNOS
- Group 3: Placebo followed by Autologous EPCs transfected with eNOS
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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 ≥"
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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