In coronary artery disease atherosclerosis leads to a decrease in lumen diameter of the large epicardial arteries, causing a deficit in blood flow known as ischemia. This ischemia can cause chest pain, referred to as angina pectoris. Refractory angina pectoris is a disabling condition with an adverse prognosis with a high mortality rate. This severe disorder has a significant morbidity and impact on quality of life. Many patients have very limiting complaints, despite optimal medical therapy.
Conditions
Interventions
Product Name: Bone marrow-derived mononuclear cells
Product Code: P10
Pharmaceutical Form: Suspension for injection
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Having received intramyocardial bone marrow cell injection in study P02.051 (Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Refractory Angina Pectoris and Ischemia, a two-phased study of safety, feasibility and efficacy) or P05.025 (Efficacy assessment of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia, a randomized, double blind, placebo controlled study) - Disabling refractory angina pectoris despite optimal medical therapy - Residual reversible ischemia on GATED-SPECT imaging - No candidate for (repeat) revascularization. - Male or female, > 18 years old - Patients must be stable and not be in a setting of life-threatening heart failure (LVEF>35%) - Able to perform an exercise tolerance test prior to therapy - Able and willing to undergo all the tests used in this protocol including the traveling involved. - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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) as bone marrow cell infusion might promote tumor growth through induction of angiogenesis in the tumor. - Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before the injection procedure. - Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure) - Bleeding diathesis or HIV infection - Any other condition that, in the opinion of the investigator, could pose a significant threat to the subject if the investigational therapy was to be initiated. - Inability to undergo cardiac catheterization or nuclear testing - Inability to follow the protocol and comply with follow-up requirements - Candidates for surgical of percutaneous intervention - Mechanical aortic valve prosthesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We intend to assess the efficacy of repeat injection of bone marrow cells in patient with residual or recurrent refractory angina pectoris. Specifically, we want to answer the question whether injection of autologous mononuclear bone marrow cells into the myocardium of no-option patients with refractory angina and documented ischemia leads to an improvement in quality of life, myocardial perfusion, excercise capacity and myocardial function.;Secondary Objective: Repeat injection of autologous mononuclear bone marrow cells into the myocardium of no-option patients with residual or recurrent refractory angina pectoris and documented ischemia is safe with respect to arrhythmia's and periprocedural myocardial damage.;Primary end point(s): Efficacy: - Gated-SPECT: stress and rest perfusion score - FDG-SPECT: assessing viability and hibernation - MRI: left ventricular global ejection fraction - Echocardiography:left ventricular wall motion - Exercise tolerance testing with VO2 max determination - Quality of Life will be assessed using the Seattle Angina Questionnaire, translated into Dutch. Safety: - holter recording: to assess the occurrence of arrhytmia's - blood sampels: to assess possible inflammation and myocardial damage | — |
Countries
Netherlands
Outcome results
None listed