Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy

Heart Disease Clinical Trial

— Alster-Star  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01144221
• Other study ID #: 1764
• Secondary ID: 2008-008368-28
• Status: Terminated
• Phase: N/A
• First received: June 14, 2010
• Last updated: April 6, 2018
• Start date: May 2010
• Est. completion date: February 2015

Study information

• Verified date: August 2012
• Source: Asklepios proresearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Asklepios Clinic St. Georg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Kai Jaquet, PhD, DSc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LVEF Value	LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection	12 months