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Cell therapy for cardiac repair through mobilization of hematopoietic stem cells and endothelial progenitors in patients with chronic ischemic cardiomyopathy. - NA

Conditions
Chronic ischemic cardiac disease
Registration Number
EUCTR2004-004545-18-BE
Lead Sponsor
CHU Sart Tilman
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
24
Inclusion Criteria

- Stable chronic ischemic cardiopathy
- Optimal drug treatment
- No possible cardiac surgery or angioplasty
- NYHA class II-IV
- Left ventricular ejection fraction <40%
- Collateral circulation and/or hibernating myocardium
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

- Inclusion criteria not fully met
- Previous neoplasia (except in situ cervical cancer or non-melanoma skin cancer)
- HIV, HBsAg or HC positive status
- Hematological condition potentially impairing response to haematopoietic growth factors
- Active infection or inflammatory disorder
- Uncontrolled hypertension
- Allergy to G-CSF or EPO
- Hb >16 g/dl
- Blood transfusion dependance

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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