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

未提供0 个研究点目标入组 23 人开始时间: 2010年6月17日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

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