Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Study Overview
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Brief Summary
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Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

Detailed Description
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Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia. 4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.

Official Title
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Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Conditions
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Myocardial Ischemia, Coronary Heart Disease

Intervention / Treatment
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* Biological: stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class >_ 2 Reduced exercise time < 10 min No further revascularization options Exclusion Criteria: Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF < 25 % NYHA > II

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesenchymal stromal cell<br>Mesenchymal stromal cell | Biological: stem cell<br>* mesenchymal stromal cell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in myocardial perfusion measured by SPECT |  | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 6 months after treatment | 
| Improvement in myocardial perfusion and function measured by PET and MR |  | 6 months after treatment | 
| Exercise time |  | 6 months after treatment | 
| Clinical angina status |  | 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial ischemia, stem cell, mesenchymal, myocardial perfusion