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Cell Therapy

B2 for Heart Attack

Phase 1 & 2
Waitlist Available
Led By Emerson C. Perin, MD, PhD
Research Sponsored by Angioblast Systems
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 3 years
Awards & highlights

Study Summary

Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI. SecondaryObjective The secondary objectives are to explore functional efficacy for subsequent study design, as well as late-term dose related tolerance, by: Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to cardiac function on Days 90, 180, and 1 year Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36), Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New York Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years Evaluating follow-up safety through Day 360 Providing preliminary data to support dose selection for future studies

Eligible Conditions
  • Heart Attack

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
Secondary outcome measures
Explore efficacy for subsequent study design and dose related tolerance: •Effect related to cardiac function.•Change from baseline in SF-36, KCCQ, SAQ, and the NYHA Classification.•Follow-up safety through Day 360 • Dose selection for future stu

Trial Design

6Treatment groups
Experimental Treatment
Group I: C2Experimental Treatment1 Intervention
2 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
Group II: C1Experimental Treatment1 Intervention
5 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection
Group III: B2Experimental Treatment1 Intervention
3 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
Group IV: B1Experimental Treatment1 Intervention
5 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection
Group V: A2Experimental Treatment1 Intervention
5 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
Group VI: A1Experimental Treatment1 Intervention
5 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Mesenchymal Precursor Cells (MPCs)
2014
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Angioblast SystemsLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Emerson C. Perin, MD, PhDPrincipal InvestigatorTexas Heart Institute/St. Luke's Hospital
1 Previous Clinical Trials
3 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
2008. "Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00555828.
All > Heart Attack
~1 spots leftby Apr 2025
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