CSCC_ASC Therapy in Patients With Severe Heart Failure

JKastrup

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Biological: Allogeneic adipose derived stem cells (CSCC_ASC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02387723

CSCC_ASC1

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stem cell therapy

Experimental group

Description:

Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart

Treatment:

Biological: Allogeneic adipose derived stem cells (CSCC_ASC)