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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell therapy | Experimental | Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic adipose derived stem cells (CSCC_ASC) | Biological | Culture expanded allogeneic adipose derive stem cells (CSCC_ASC) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Kastrup, Professor MD | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet | Copenhagen | 2100 | Denmark |
Data can be shared for Scientific collaboration
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months |