CSCC_ASC Therapy in Patients With Severe Heart Failure

Study Overview
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Brief Summary
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The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.

Detailed Description
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Patients with heart failure will be treated with culture expanded adipose tissue derived mesenchymal stem cells from healthy donors stored in nitrogen until use. The cells will be injected directly into the myocardium using the NOGA XP method. The patients will be followed for 6 months for safety and efficacy registration.

Official Title
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Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study

Conditions
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Heart Failure

Intervention / Treatment
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* Biological: Allogeneic adipose derived stem cells (CSCC_ASC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 to 80 years of age Signed informed consent Chronic stable IHD HF (NYHA II-III) LVEF ≤45% Maximal tolerable angina and heart failure medication Medication unchanged two months prior to inclusion Angiography within six months of inclusion No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device Exclusion Criteria: Heart Failure (NYHA I or IV) Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion Other revascularisation treatment within four months of treatment Moderate to severe valvular disease or valvular disease with option for valvular surgery Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections Patients with reduced immune response or treated with immunosuppressive medication History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma Pregnant women Other experimental treatment within four weeks of baseline tests Participation in another intervention trial

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell therapy<br>Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart | Biological: Allogeneic adipose derived stem cells (CSCC_ASC)<br>* Culture expanded allogeneic adipose derive stem cells (CSCC_ASC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells | Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g) | The secondary objectives are to demonstrate improvement in in left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g) between baseline and follow-up | 6 months |