Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy

NCT01144221 | Terminated

• 2 other identifiers: 17642008-008368-28
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Disease

Keywords

Chronic Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• LVEF Value

  LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection

  12 months

Study Arms (1)

Stem cell treatment

EXPERIMENTAL

Patients treated via stem cell injection

Procedure: Intramyocardial Cell therapy

Interventions

Intramyocardial Cell therapy PROCEDURE

Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation

Stem cell treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kai Jaquet, PhD, DSc: lead

Study Sites (1)

Asklepios Clinic St. Georg

Hamburg, 20099, Germany

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Korff Krause, Dr. med.

  Asklepios proresearch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Stem Cell Lab

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: February 1, 2015
• Last Updated: April 9, 2018

Record last verified: 2012-08

Locations

DE (1)