Efficacy assessment of repeat intramyocardial injection of autologous bone marrow cells in previously responding no-option patients with residual refractory angina pectoris and documented ischemia - Repeat cell therapy for refractory angina

• Conditions: 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.

• Registration Number: EUCTR2009-017924-18-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified