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Gene and Cell Therapy for Heart Attack (ENACT-AMI Trial)
ENACT-AMI Trial Summary
This trial is testing a new way to treat heart disease by using a combination of gene and cell therapy.
ENACT-AMI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENACT-AMI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ENACT-AMI Trial Design
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Who is running the clinical trial?
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- I had heart muscle weakness before my major heart attack.Your heart's pumping function, measured by echocardiography, must not be too high.I am between 18 and 80 years old.I have a serious heart valve problem that hasn't been fixed.My heart's pumping ability is good after a heart attack.I cannot undergo apheresis.I have a history of HIV or hepatitis B/C.I am on long-term medication for an autoimmune disease.I had a heart attack in the last 30 days confirmed by an ECG.I have not had a stroke or mini-stroke in the last 6 months.I have a serious heart artery problem.My heart and blood circulation are stable.You do not meet the requirements for having an MRI.I am a woman who is not pregnant and meets the study's fertility or menopause criteria.Your kidneys don't clean your blood well enough.I have had cancer within the last 5 years.I had a successful stent placement in a heart artery within the last month.Your heart's pumping ability increases by more than 10% from the first check-up.You have had an allergic reaction to gentamycin or amphotericin in the past.You have a history of a condition called Heparin-Induced Thrombocytopenia.I have had serious heart rhythm problems not caused by my initial heart attack.You have blockages in your heart arteries, except for the specific one being studied.I have undergone cell or gene therapy before.You have a history of not following the rules or instructions.
- Group 1: Plasma-Lyte A and 25% autologous plasma
- Group 2: Autologous EPCs
- Group 3: Autologous EPCs Transfected with human eNOS
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 there any ongoing or past research projects that have used Autologous EPCs?
"There are a total of 112 active clinical trials testing Autologous EPCs. 30 of those studies have progressed to Phase 3. The majority of these studies are located in Calgary, Alberta; however, there are 390 research centres running these tests across the world."
To what extent would I be involved if I chose to partake in this research?
"This particular clinical trial has space for 47 individuals that currently have anteroseptal myocardial infarction. Furthermore, it is essential that these potential participants also meet the following: They must be within the age range of 18-80, male or female, and considered hemodynamically stable at time of enrollment and immediately prior to cell delivery."
Will this research project be testing any subjects who are senior citizens?
"this specific clinical study only accepts patients that fall between 18 to 80 years old. If a patient does not meet this age criteria, there are 29 other trials they could potentially enroll in. For patients above the age of 65, there are 455 different trials available."
Why are Autologous EPCs often prescribed?
"Autologous EPCs is a medication used to ameliorate the symptoms of diarrhea. However, it has also been found effective in treating other conditions like general surgery, terminal state, and urine alkalinization therapy."
How many people are being chosen for this research project?
"As of December 1st 2020, this particular clinical trial is no longer admitting patients. However, there are presently 373 other trials for anteroseptal myocardial infarction and 112 studies for Autologous EPCs that are still looking for participants."
Has the FDA cleared Autologous EPCs for therapeutic use?
"Autologous EPCs received a score of 2 on the Power scale because there is only preclinical data supporting its safety, and no efficacy data as this is a Phase 2 trial."
At how many different locations can patients participate in this trial?
"There are 4 operational sites for this study, which can be found in the cities of Montreal, Toronto and Québec. Additionally, there are other locations in 4 additional municipalities. If possible, choose the site that is closest to your home to cut down on travel time commitments."
Is it possible to sign up for this experiment?
"Unfortunately, this research project is no longer recruiting patients. It was originally posted on July 19th, 2013 and last updated December 1st, 2020. However, there are other ongoing trials that might be of interest; presently, 373 studies are actively recruiting participants with anteroseptal myocardial infarction and 112 studies for Autologous EPCs are also searching for candidates."
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