Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy (Alster-Star)

Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction

This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.

Study Overview

• Status: Terminated
• Conditions: Heart Disease
• Intervention / Treatment: Procedure: Intramyocardial Cell therapy

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20099
    • Asklepios Clinic St. Georg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation
• wall motion dysfunction of any territory
• left bundle branch block
• Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation

Exclusion Criteria:

• patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
• with relevant valvular disease;
• Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm,
• with overt heart failure, other than ischemic cardiomyopathy,
• with history of stroke and/or transient ischemic attack (TIA),
• with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
• with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
• with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
• atrial fibrillation with average heart rate >70 bpm
• pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
• with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
• patients with a chronic or acute HIV-, HBV-, HCV-infection;
• improvement of more than 15% of LVEF 3 months after CRT-device implantation
• patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
• patients who are currently participating in another investigational drug or device study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem cell treatment; Patients treated via stem cell injection	Procedure: Intramyocardial Cell therapy; Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LVEF Value	LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection	12 months

Collaborators and Investigators

• Sponsor: Kai Jaquet, PhD, DSc
• Investigators: Principal Investigator: Korff Krause, Dr. med., Asklepios proresearch

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Ischemic Heart Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 1764; 2008-008368-28 (EudraCT Number)