Your session is about to expire
← Back to Search
Stem Cell Therapy
Stem Cell Therapy for Heart Attack (MARVEL Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Bioheart, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35 percent by multiple gated acquisition scan (MUGA)
Defined region of myocardial dysfunction related to previous MI involving the anterior, lateral, posterior or inferior walls including the apical septum (excluding the basal septum) assessed by a large area of akinesia in the left ventricle (using DSE at screening)
Must not have
Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, including any significant myopathy
Patient will require revascularization within six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing whether injecting a person's own stem cells into heart muscle tissue can improve heart performance after one or more heart attacks.
Who is the study for?
Adults aged 18-80 with chronic heart failure (Class II-IV), stabilized on specific heart medications, and an ejection fraction of ≤35%. They must have had a heart attack affecting certain heart walls and cannot be candidates for revascularization. Excluded are those needing imminent heart procedures, with recent severe cardiac events or interventions, uncontrolled conditions, or unable to perform basic physical tests.
What is being tested?
The trial is testing the safety and effectiveness of injecting a patient's own stem cells (MyoCell) into their heart muscle after suffering from one or more heart attacks. The goal is to see if this can improve the function of the patient's heart.
What are the potential side effects?
Potential side effects may include reactions at the injection site, infection risk due to stem cell implantation, immune system responses against implanted cells, arrhythmias (irregular heartbeat), and general discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is 35% or less.
Select...
My heart has a large area not moving well due to a past heart attack.
Select...
I am on the highest dose of ACE inhibitors that I can tolerate.
Select...
I am between 18 and 80 years old.
Select...
I am between 18 and 80 years old.
Select...
I have chronic heart failure classified as NYHA Class II-IV.
Select...
I am on the highest dose of beta blockers that I can tolerate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have a muscle biopsy due to a significant muscle condition.
Select...
I need a procedure to improve blood flow within six months.
Select...
I am on IV drug therapy, either continuously or intermittently.
Select...
I cannot perform a 6-minute walk test due to severe health issues unrelated to heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: High DoseActive Control1 Intervention
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Group II: Low DoseActive Control1 Intervention
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Group III: ControlPlacebo Group1 Intervention
Patient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
Find a Location
Who is running the clinical trial?
Bioheart, Inc.Lead Sponsor
8 Previous Clinical Trials
776 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is 35% or less.I cannot have a muscle biopsy due to a significant muscle condition.You've had certain heart rhythm problems or a device called an AICD activate in the past 90 days.Your BNP or NT pro-BNP levels are higher than normal.My heart condition has been stable for 60 days with the right medication and diet.I need a procedure to improve blood flow within six months.I am on IV drug therapy, either continuously or intermittently.I cannot perform a 6-minute walk test due to severe health issues unrelated to heart failure.I have severe heart failure but can take medications that affect aldosterone.I have severe heart failure but can take specific heart medications.My heart condition does not require or cannot be treated by reopening blocked arteries, confirmed by tests within the last year.My heart has a large area not moving well due to a past heart attack.I am on the highest dose of ACE inhibitors that I can tolerate.I am not pregnant, and I use or am willing to use reliable birth control.I am between 18 and 80 years old.The heart muscle in the area to be treated is too thin.I am between 18 and 80 years old.I have chronic heart failure classified as NYHA Class II-IV.I am on the highest dose of beta blockers that I can tolerate.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: High Dose
- Group 3: Low Dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger