MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)

Study Overview
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Brief Summary
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Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital admissions for acute chest pain. In spite of improved treatments still many patients with CAD have daily attacks of severe chest pain and severely reduced life quality. The investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.

Detailed Description
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In an open single centre pilot study we have evaluated the safety and efficacy of MSC treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated with MSCs had significant increased exercise capacity, reduction in angina, angina attacks and medication and in life quality at 6 months follow-up. For all the parameters there was a tendency towards improved outcome with increasing number of cells. The treatment with MSCs was safe. The investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.

Official Title
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MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)

Conditions
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Chronic Ischemic Heart Disease

Intervention / Treatment
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* Biological: MSC
* Biological: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CCS III - IV Coronary artery stenosis/occlusion not treatable with invasive procedures LVEF > 40% ETT between 2 - 10 min Exclusion Criteria: Valvular heart disease FEV1 < 1 Severe systemic disease Acute coronary syndrome > 2 months

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MSC<br>Adipose derived stem cells | Biological: MSC<br>* No of cells after culture expansion<br>* Other names: Mesenchymal stem cells;|
| Placebo Comparator: Saline<br> | Biological: Saline<br>* 3 cc saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise test |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients