Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy
Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
1 other identifier
interventional
10
1 country
1
Brief Summary
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 13, 2017
September 1, 2016
3.7 years
July 30, 2013
December 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
3 months
Secondary Outcomes (3)
Change in quality of life
3 months, 6 months, 12 months
Changes in exercise capacity
1 year
Changes in plasma inflammatory markers
6 months
Study Arms (1)
MSCs injection
EXPERIMENTALInjection of autologous bone marrow-derived mesenchymal cells
Interventions
MSCs cells will be injected in two aliquots of 10 ml by catheterism
Eligibility Criteria
You may qualify if:
- Chronic coronary artery disease
- NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
- Ejection fraction between 35% and 55%.
- Stable medical therapy for at least one month
- Patients clinically treated with coronary angioplasty with or without intraluminal stent.
- Patients with surgical revascularization and without the possibility of new invasive intervention.
You may not qualify if:
- Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
- An active uncontrolled infection.
- Pregnancy.
- Mental disability.
- Terminal illnesses.
- Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
- Life perspective by other diseases under 1 year.
- History of severe arrhythmias
- Renal dysfunction or against medication
- Inability to perform cardiac catheterization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexandra Cristina Senegaglialead
- Santa Casa de Misericórdia de Curitiba, Brazilcollaborator
- Fundação Araucáriacollaborator
Study Sites (1)
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulo Brofman, PhD
Pontifícia Universidade Católica do Paraná
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 1, 2013
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
March 1, 2016
Last Updated
December 13, 2017
Record last verified: 2016-09