Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients With Ischemic Dilated Cardiomyopathy

NCT01720888 | Unknown Phase 2 DMC

• 1 other identifier: ERGS/1/2011/SKK/UKM/02/72
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the recent advances in medical and surgical treatment, heart failure resulting from ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a result of severe coronary artery disease (CAD). LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.This study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population.

Conditions

Ischemic Dilated Cardiomyopathy

Keywords

Autologous; Bone Marrow; Mesenchymal Stem Cells; Ischemic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Change in LV ejection fraction as measured by echocardiogram and cardiac MRI after implantation

  1 month, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (5)

• Changes in functional status

  12 months

• Improvement in other LV parameters as assessed by echocardiogram and cardiovascular magnetic resonance(CMR).

  1 months, 3 months, 6 months, 9 months, 12 months

• Resolution of scar tissue volume/area on cardiac MRI

  6 months, 12 months.

• Change in serum N Terminal-pro B type natriuretic peptide(NT-proBNP)level

  1 month, 6 months, 12 months

• Freedom from major adverse cardiac events as defined by myocardial infarction, hospitalization for angina, myocardial infarction or heart failure, or death (all cause of mortality).

  1 month, 3 months, 6 months, 9 months, 12 months

Other Outcomes (4)

• No peri-procedural complications

  1 month, 3 months, 6 months, 9 months, 12 months

• Significant improvement in overall left ventricular function

  12 months

• Resolution of scar tissue

  6 months, 12 months

Study Arms (2)

Maximal medical therapy

NO INTERVENTION

Maximal medical therapy which comprises of optimal pharmacological therapy

Maximal medical therapy and BM-MSCs

EXPERIMENTAL

Autologous Bone marrrow-derived mesenchymal stem cells implantation

Other: BM-MSCs

Interventions

BM-MSCs OTHER

Intracoronary implantation of bone marrow-derived mesencymal stem cells

Also known as: Bone marrow-derived mesenchymal stem cells implantation

Maximal medical therapy and BM-MSCs

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 35 to 75 years
• diagnosed to have ICM confirmed by previous coronary angiogram showing significant coronary artery disease \>70% or history of previous myocardial infarction.
• myocardial infarction event occured 6 months or longer from time of screening.
• LV ejection fraction of ≤40% by echocardiogram or cardiac MRI.

You may not qualify if:

• Likelihood of heart failure from other causes such as idiopathic, infective or metabolic cardiomyopathy,valvular heart disease and pericardial disease.
• patients who had undergone a coronary artery bypass graft(CABG) procedure.
• patients who do not have any visible/significant myocardial scar.
• patients with any cardiovascular metallic implantation.
• any contraindication to bone marrow aspiration
• any contraindication to coronary contrast angiography and angioplasty.
• any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV.
• any past history of neoplasia and primary haematological disease.
• any current, past or paroxysmal cardiac arrhythmias.
• renal impairment indicated by creatinine clearance of less than 30 ml/min.
• liver impairment indicated by serum alanine transferase level at 4 times greater than normal value.

Sponsors & Collaborators

• National University of Malaysia: lead
• Cytopeutics Sdn. Bhd.: collaborator

Study Sites (1)

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Study Officials

• Oteh Maskon, MB Bch

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 2, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

MY (1)