Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium

Congestive Heart Failure Clinical Trial

Official title:

Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326989
• Other study ID #: 2005-005709-50
• Secondary ID: Cellwave CHF
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 16, 2006
• Last updated: March 20, 2017
• Start date: May 2006
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.

Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy

Description:

Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with chronic ischemic heart disease

• Patients with anterior myocardial infarction > 3months

• EF < 50% or NYHA II-IV

• Age 18-80

• Informed consent

Exclusion Criteria:

• Ventricular thrombus

• Infarct < 3 months.

• Active infection or fever

• Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)

• HIV Infection oder active Hepatitis

• Neoplastic disease w/o complete remission within 5 years

• Stroke < 3months

• Creatinine > 2 mg/dl

• Relevant Liver disease (GOT > twice the upper limit).

• Anemia (Hemoglobin <10 mg/dl)

• Thrombocytopenia < 100.000/µl

• Allergies to Aspirin, Clopidogrel, Heparin

• History of bleeding disorder

• History of coagulopathy

• Gastrointestinal Bleeding < 3 months

• Surgery or Trauma < 2 months

• Pregnancy

• Mental Retardation

• Participation in other clinical study < 1 month

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy

Locations

Country	Name	City	State
Germany	Div. of Cardiology , University of Frankfurt	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in global ejection fraction on LV angiography		4 months
Secondary	Global or regional wall motion at 4 months and 1 year		4 months
Secondary	NYHA Class		4 months
Secondary	NT BNP levels		4 months
Secondary	MACE		4 months
Secondary	Life quality		4 months