Human Umbilical Cord Stroma MSC in Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-02

Study Completion Date

2018-12-30

Brief Summary

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The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior to the cell administration. This 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of age. The efficiency of the therapy will be evaluated according to the parameters measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.

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Detailed Description

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Conditions

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Chronic Ischemic Cardiomyopathy Coronary Artery Bypass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Allogeneic umbilical cord MSC group

Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)

Group Type EXPERIMENTAL

stem cell transplantation

Intervention Type BIOLOGICAL

Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Autologous bone marrow-derived MNC group

Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)

Group Type ACTIVE_COMPARATOR

stem cell transplantation

Intervention Type BIOLOGICAL

Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Control group

20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF\<%45) whom will not received any further transplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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stem cell transplantation

Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Ischemic hearth disease who will experience CABG
* %25\<EF\<%45
* NYHA class II-IV patients
* hemodynamically stable

Exclusion Criteria

* Patient's in approval
* Acute cardiac decompensation
* Acute myocardial infarction
* Congenital heart disease
* Additional surgical heart disease other than coronary artery disease
* Malign arrhythmia
* All malignancies
* HbA1c level \>%10 (86 mmol/mol) type II diabetes mellitus
* Severe liver dysfunction
* Severe COPD
* Coagulopathy
* Immunosuppressive treatment
* Acute hepatitis, hepatitis B, C and HIV infection
* Chronic liver and renal failure
* Collagen tissue disease
* Stroke
* TB
* Hematological diseases
* Socially and mentally disabilities

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No