Progenitor Cell Therapy in Dilative Cardiomyopathy

Heart Failure, Congestive Clinical Trial

Official title:

Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284713
• Other study ID #: TOPCARE-DCM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 31, 2006
• Last updated: February 17, 2009
• Start date: May 2004
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.

Description:

Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery.

Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 8-80

• Dilated Cardiomyopathy, Ejection fraction < 40%

• LVEDD > 60mm

• Stable clinical condition within last 6 months

• Written informed consent

Exclusion Criteria:

• Myocardial infarction or coronary intervention in the past

• Change of medical therapy within the last 6 weeks prior to cell therapy

• Tumor within last 5 years or incomplete remission

• Active infection

• Active bleeding

• Stroke within last 2 years

• Surgery or trauma within last 2 months

• Uncontrolled hypertension

• HIV infection

• Chronic inflammatory disease

• Liver disease (GOT > 2x upper normal limit)

• Renal dysfunction (creatinin > 2.0mg/dl)

• Thrombopenia < 100.000

• Anemia (hemoglobin < 8.5 g/dl)

• Mental retardation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Heart Failure
• Heart Failure, Congestive
• Stem Cell Transplantation

Intervention

Procedure:
• intracoronary infusion of BMC
catheter delivery of stem cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV function (Ejection fraction within 3 months) Simpson		4 months