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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
MARVEL Trial 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.Check my eligibility
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.See study design
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.
MARVEL Trial 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.
MARVEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-minute walk test
Quality of Life Questionnaire
Secondary outcome measures
Hospitalization occurrences
MARVEL 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many places are managing this experiment?
"Along with 33 other medical facilities, this trial is currently enrolling patients at Newark Beth Israel Medical Center in Newark, New jersey, Texas Heart Institute in Houston, Texas, and Mercy Gilbert Medical Center in Gilbert, Arizona."
Answered by AI
Is this study limited to individuals under the age of 25 years?
"This particular clinical trial only enrolls patients aged 18-80. If you are outside of this age bracket, there are 34 other trials for people under 18 and 1060 for patients over 65."
Answered by AI
Are subjects still being recruited for this trial?
"No, this study is not recruiting patients at the moment. The last update on ClinicalTrials.gov was on July 20th, 2017. There are, however, 1074 other studies that are still recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Texas
How old are they?
18 - 65
What site did they apply to?
Emory/Crawford Long
Texas Heart Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
YES IF I HAPPEN NOT TO GET REAL STEM CELL DURING TRAIL WILL THEY HONOR ME TO GET ANOTHER TRAIL AT TOP VISIT AGAIN ?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have had heart failure for 19 years. I am 69 years old. 11/09/1953. Diagnosed in July, 2004. I have both systolic and diastolic HF.
PatientReceived 2+ prior treatments
I AM RETIRED AND I WANT TO SEE IF I GET MORE SUPPORT FROM ANY HEART DR.. I WANT TRY NEW THING LIKE CCM VAD OR BRAND NEW CRTD ( I WEAR CRT D FOR MORE THAN FIFTEEN YEARS NOW ) I LIKE TO TRY FOR STEM CELLS ETC.. NOTE I AM DEAF BUT EAsily communicate via device or interprter . i cAN WRITE.
PatientReceived no prior treatments
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