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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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially join this clinical trial based on my eligibility?
"To qualify for this research protocol, individuals must have coronary artery disease and be between 18 to 70 years old. The investigators wish to recruit a total of 21 patients."
Answered by AI
Are there any remaining openings to join this experimentation?
"Data hosted on clinicaltrials.gov suggests that this investigation is no longer recruiting new participants, having been initially posted in April 2006 and last altered in the spring of 2022. Fortunately, there are 543 other studies at present looking to enrol patients."
Answered by AI
Are any individuals aged 55 and over being accepted into this experiment?
"This clinical trial is open to participants aged 18 and over, with the upper age limit set at 70."
Answered by AI
Has the FDA cleared Stem Cell Therapy for widespread use?
"The safety of stem cell therapy is assessed to be a 1 since this is an early phase experiment and limited clinical data exists which supports its efficacy and security."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Heart Institute/Baylor St. Luke's Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
What questions have other patients asked about this trial?
Yes of course. Non disclosures for wife and family? Houston stay accommodations etc. Daily diet changes? Trial guidelines?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have 3 leaking valves. One being the aortic valve and one being the pulmonary valve. I am at about 8% body fat. heart rate is 55bpm. My BP is 110/75 exercise daily. I have a deep understanding of human anatomy and have been following leading edge research for a while. Before it gets out of hand. Personally I have small children at home and want to be around a while with a better quality of life. Can send you medical records that are current my labs etc. Just had several test done. Will be having upper and lower Gi tract scoped in a few weeks.
PatientReceived 2+ prior treatments
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