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Stem Cell Therapy
Stem Cell Therapy for Coronary Artery Disease
Phase 1
Waitlist Available
Led By Emerson Perin, MD, PhD
Research Sponsored by Texas Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
Study Summary
This trial is testing whether injecting stem cells into the heart can help grow new blood vessels to supply the heart muscle that is currently not getting enough blood.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events
Secondary outcome measures
Canadian Cardiovascular (CCS) Angina Score
Echocardiography (EF) Percent (%)
Echocardiography (EF)Percent (%)
+8 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Stem Cell TherapyActive Control1 Intervention
Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Group II: ControlPlacebo Group1 Intervention
Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
At 6 months, subject is offered stem cell therapy and then followed for 12 months.
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Who is running the clinical trial?
Texas Heart InstituteLead Sponsor
7 Previous Clinical Trials
4,810 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
31 Patients Enrolled for Coronary Artery Disease
CHI St. Luke's Health, TexasOTHER
5 Previous Clinical Trials
1,514 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
235 Patients Enrolled for Coronary Artery Disease
AldagenIndustry Sponsor
6 Previous Clinical Trials
279 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to walk on a treadmill.You have a stable heart rate, blood pressure, and circulation.You had a heart attack in the last 30 days.You have atrial fibrillation.You have a heart condition called coronary artery disease that cannot be treated with surgery or stents.You have a serious problem with one or more of your heart valves.
Research Study Groups:
This trial has the following groups:- Group 1: Stem Cell Therapy
- Group 2: Control
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.
Coronary Artery Disease Patient Testimony for trial: Trial Name: NCT00314366 — Phase 1
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