Clinical trial NCT02387723: CSCC_ASC Therapy in Patients With Severe Heart Failure
Official title: Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
timeFrame: 6 months
Secondary outcomes:
measure: Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens Kastrup, Professor MD
role: STUDY_DIRECTOR
References: