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

• ClinicalTrials.gov Identifier: NCT01144221
• Recruitment Status: Terminated
• First Posted: June 15, 2010
• Last Update Posted: April 9, 2018
• Sponsor: Kai Jaquet, PhD, DSc
• Information provided by (Responsible Party): Kai Jaquet, PhD, DSc, Asklepios proresearch

Tracking Information

• First Submitted Date: June 14, 2010
• First Posted Date: June 15, 2010
• Last Update Posted Date: April 9, 2018
• Actual Study Start Date: May 2010
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2010)

LVEF Value [ Time Frame: 12 months ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Heart Disease

Intervention

Procedure: Intramyocardial Cell therapy

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

Study Arms

Experimental: Stem cell treatment

Patients treated via stem cell injection

Intervention: Procedure: Intramyocardial Cell therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 5, 2018): 6
• Original Estimated Enrollment (submitted: June 14, 2010): 20
• Actual Study Completion Date: February 2015
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01144221
• Other Study ID Numbers: 1764; 2008-008368-28 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kai Jaquet, PhD, DSc, Asklepios proresearch
• Study Sponsor: Kai Jaquet, PhD, DSc
• Collaborators: Not Provided

Investigators

• Principal Investigator: Korff Krause, Dr. med.; Asklepios proresearch

• PRS Account: Asklepios proresearch
• Verification Date: August 2012