Bypass Surgery and CD133 Marrow Cell Injection for Treatment of Ischemic Heart Failure

NCT00462774 | Completed Phase 2 DMC

• 1 other identifier: DHZB/CARDIO133/2007/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cell transplantation for treatment of heart failure is a novel field of translational research that offers the perspective of developing curative approaches by regenerating or "rejuvenating" lost and/or diseased myocardium and inducing growth of new blood vessels. Based on the safety and preliminary efficacy testing in previous trials, a stringent efficacy testing will be performed in this study. Sixty patients who had myocardial infarction in the past and now need bypass surgery for ongoing coronary artery disease will undergo either bypass surgery and placebo treatment or bypass surgery and injection of CD133 bone marrow cells directly in the heart muscle. The study will be fully blinded, i.e. neither the patient nor the surgeon knows what substance is injected (placebo or cell product). Patients will be followed for 6 months and various heart function measurements will be performed.

Conditions

Coronary Artery Disease With Need for Bypass Surgery; Myocardial Ischemia, Angina Pectoris; Congestive Heart Failure; Previous Myocardial Infarction

Keywords

Myocardial infarction; Heart failure; Cell therapy; Bone marrow; CD133; Bypass surgery; Stem cells

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction at rest, measured six months postoperatively, measured by MRI

Secondary Outcomes (8)

• Change in LVEF compared with preoperatively and early postoperatively

• Regional contractility in the AOI

• Physical exercise capacity determined by 6 minute walk test

• Perfusion in the AOI

• Change in LV dimensions

Interventions

Intramyocardial injection of autologous CD133+ marrow cells PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery disease with indication for CABG surgery
• Reduced global left ventricular ejection fraction by transthoracic echocardiography at rest (EF ≤ 35%)
• Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
• Informed consent of the patient
• Age \> 18 years

You may not qualify if:

• Emergency operation
• Presence of aortic valve disease requiring concomitant valve replacement
• Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia
• History of ventricular arrhythmia (≥ Lown III)
• Impaired ability to comprehend the study information
• Absent informed written consent
• Apparent infection (CRP ≥ 20 mg/L, fever (≥38.5° C)
• Acute myocardial infarction
• contraindication for MRI assessment
• Pregnancy or lactation

Sponsors & Collaborators

• German Heart Institute: lead
• Miltenyi Biomedicine GmbH: collaborator

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Related Publications (3)

• Stamm C, Westphal B, Kleine HD, Petzsch M, Kittner C, Klinge H, Schumichen C, Nienaber CA, Freund M, Steinhoff G. Autologous bone-marrow stem-cell transplantation for myocardial regeneration. Lancet. 2003 Jan 4;361(9351):45-6. doi: 10.1016/S0140-6736(03)12110-1.

  PMID: 12517467 BACKGROUND

• Stamm C, Kleine HD, Choi YH, Dunkelmann S, Lauffs JA, Lorenzen B, David A, Liebold A, Nienaber C, Zurakowski D, Freund M, Steinhoff G. Intramyocardial delivery of CD133+ bone marrow cells and coronary artery bypass grafting for chronic ischemic heart disease: safety and efficacy studies. J Thorac Cardiovasc Surg. 2007 Mar;133(3):717-25. doi: 10.1016/j.jtcvs.2006.08.077. Epub 2007 Feb 1.

  PMID: 17320570 BACKGROUND

• Nasseri BA, Ebell W, Dandel M, Kukucka M, Gebker R, Doltra A, Knosalla C, Choi YH, Hetzer R, Stamm C. Autologous CD133+ bone marrow cells and bypass grafting for regeneration of ischaemic myocardium: the Cardio133 trial. Eur Heart J. 2014 May 14;35(19):1263-74. doi: 10.1093/eurheartj/ehu007. Epub 2014 Feb 3.

  PMID: 24497345 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Roland Hetzer, MD, PhD

  German Heart Institute

  STUDY DIRECTOR

• Boris Nasseri, MD

  German Heart Institute

  PRINCIPAL INVESTIGATOR

• Christof Stamm, MD

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

DE (1)