Heart Failure
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALAllogeneic adipose derived stem cells (CSCC_ASC)
Culture expanded allogeneic adipose derive stem cells (CSCC\_ASC)
Sponsors
JKastrup
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 30 to 80 years of age 2. Signed informed consent 3. Chronic stable IHD 4. HF (NYHA II-III) 5. LVEF ≤45% 6. Maximal tolerable angina and heart failure medication 7. Medication unchanged two months prior to inclusion 8. Angiography within six months of inclusion 9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) 10. 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 11. Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device
Exclusion criteria
1. Heart Failure (NYHA I or IV) 2. Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion 3. Other revascularisation treatment within four months of treatment 4. Moderate to severe valvular disease or valvular disease with option for valvular surgery 5. 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 6. Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia 7. Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections 8. Patients with reduced immune response or treated with immunosuppressive medication 9. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma 10. Pregnant women 11. Other experimental treatment within four weeks of baseline tests 12. Participation in another intervention trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g) | 6 months | 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 |
Countries
Denmark
Outcome results
None listed