Ischemic heart failure is associated with significant morbidity and mortality. The number of patients with severe heart failure that remains symptomatic despite optimal pharmacological and non-pharmacological treatment increases rapidly. At present there are no widely available conventional therapeutic options for these patients who have an adverse prognosis: 2-year mortality over 50% in patients with functional class III and IV. MedDRA version: 12.0 Level: LLT Classification code 10019279 Term
Conditions
Interventions
Product Name: Bone marrow-derived mononuclear cells
Product Code: P09
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration o
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Ischemic heart failure NYHA class 3 or 4 despite optimal pharmacological and non- pharmacological therapy - No candidate for (repeat) surgery (revascularization, valve repair or ventricular reconstruction) - No candidate for (repeat) percutaneous revascularization - Optimal resynchronization therapy, or no candidate for resynchronization therapy. - Male or female, > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy) - Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before randomization. - Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal insufficiency) - Bleeding diathesis, HIV infection or pregnancy. - Any other condition that, in the opinion of the investigator, could pose a significant threat to the subject if the investigational therapy will be initiated. - Inability to undergo cardiac catheterization or nuclear testing - Inability to follow the protocol and comply with follow-up requirements - Candidate for surgery (revascularization, valve repair or ventricular reconstruction), resynchronization therapy or percutaneous revascularization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We intend to assess the efficacy of cardiac stem cell therapy in ischemic heart failure patients. Specifically, we want to answer the question whether injection of autologous mononuclear bone marrow cells (BMCs) into the myocardium of no-option patients with ischemic heart failure leads to an improvement in Quality of Life, exercise capacity, myocardial perfusion and myocardial function.;Secondary Objective: Injection of autologous mononuclear bone marrow cells (BMCs) into the myocardium of no-option patients with ischemic heart failure is safe with respect to arrhythmia's and periprocedural myocardial damage.;Primary end point(s): Efficacy: Left ventricular global ejection fraction as assessed by Gated SPECT. LV regional wall motion by echocardiography FDG-SPECT for assessment of viability and hibernation myocardial innervation imaging (MIBG-SPECT) for assessment of myocardial innervation. Exercise capacity by bicycle exercise testing with VO2 measurement. Quality of Life will be assessed using the Minnesota Living with Heart Failure questionnaire. Safety: As many patients will already have an implanted cardioverter/defibrillator (ICD), occurrence of arrhythmia’s are monitored via these devices if possible. In patients without ICD regular Holter monitoring will be performed. Moreover, blood samples will be taken to assess possible inflammation and myocardial damage. | — |
Countries
Netherlands
Outcome results
None listed