Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Myocardial Ischemia Coronary Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stromal cell

Group Type ACTIVE_COMPARATOR

stem cell

Intervention Type BIOLOGICAL

mesenchymal stromal cell

Interventions

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stem cell

mesenchymal stromal cell

Intervention Type BIOLOGICAL

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