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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004545-18-BE

Enrollment

Registered

2005-12-12

Start date

2005-04-26

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ischemic cardiac disease

Interventions

Trade Name: Neorecormon 5000 Product Name: Neorecormon 5000 IU Product Code: 205-3859/V06 Pharmaceutical Form: Solution for injection INN or Proposed INN: Epoetin beta Concentration unit: IU/ml intern

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Stable chronic ischemic cardiopathy - Optimal drug treatment - No possible cardiac surgery or angioplasty - NYHA class II-IV - Left ventricular ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the kinetics of mobilization of hematopoietic stem cells (HSC), mesenchymal stem cells (MSC) and endothelial progenitors (EP) in the peripheral blood by Granulocyte Colony-Stimulating Factor (G-CSF) and/or Erythropoietin (EPO) stimulation.;Secondary Objective: To examine the HSC, MSC and EP content in the bone marrow of patients with chronic ischemic cardiopathy, before and during mobilization by growth factors. To study the effects of stem cell mobilization on myocardial perfusion and function.;Primary end point(s): 1. Number of HSC, MSC and EP mobilized in peripheral blood 2. Kinetics of mobilization	—

Measure

Time frame

Main Objective: To study the kinetics of mobilization of hematopoietic stem cells (HSC), mesenchymal stem cells (MSC) and endothelial progenitors (EP) in the peripheral blood by Granulocyte Colony-Stimulating Factor (G-CSF) and/or Erythropoietin (EPO) stimulation.;Secondary Objective: To examine the HSC, MSC and EP content in the bone marrow of patients with chronic ischemic cardiopathy, before and during mobilization by growth factors. To study the effects of stem cell mobilization on myocardial perfusion and function.;Primary end point(s): 1. Number of HSC, MSC and EP mobilized in peripheral blood 2. Kinetics of mobilization

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026