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MSCs for Prevention of MI-induced HF (PREVENT-TAHA)

Primary Purpose

Myocardial Infarction, Acute, Myocardial Infarction First, Myocardial Infarction, Anterior Wall

Status
Recruiting
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs)
Conventional Treatment
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction, Acute focused on measuring WJ-MSCs, Myocardial infarction, Heart failure, Regenerative medicine, Tissue therapy, Stem cell therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65 years
  • Either gender
  • First myocardial infarction in the preceding 3 to 7 days
  • Post-acute myocardial infarction left ventricular ejection fraction < 40%
  • Negative pregnancy test (for women of reproductive age)
  • Written informed consent

Exclusion Criteria:

  • A history of any prior cardiac conditions (valvular, ischemic, or congenital disorders)
  • Regional wall motion abnormalities outside the region of the infarction
  • LV dysfunction due to other etiologies like non-ischemic cardiomyopathy, anthracycline use, or ethanol abuse (> 6 oz./day regularly)
  • Poor echocardiography window
  • Active infection, malignancy, or autoimmune disease

Sites / Locations

  • Al-Zahra Heart Hospital, Shiraz University of Medical SciencesRecruiting
  • Faghihi HospitalRecruiting
  • Namazee HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 2 (Control Group)

Arm Description

In the experimental group, 3-7 days after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive a single intracoronary infusion of 10^7 umbilical cord-derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) alongside conventional treatment.

In the control group, after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive only conventional treatment.

Outcomes

Primary Outcome Measures

Incidence of Heart Failure
The incidence of heart failure during the follow-up period.

Secondary Outcome Measures

Change in Left Ventricular Function from base line
Measurement of left ventricular function with echocardiography
Cardiovascular Death
Occurrence of mortality due to cardiovascular causes
Composite outcome of cardiovascular death and heart failure incidence
Occurrence of mortality due to cardiovascular causes or heart failure

Full Information

First Posted
August 29, 2021
Last Updated
September 6, 2021
Sponsor
Shiraz University of Medical Sciences
Collaborators
National Institute of Medical Research Development (NIMAD), Iran, Cell Tech Pharmed Company, Iran
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1. Study Identification

Unique Protocol Identification Number
NCT05043610
Brief Title
MSCs for Prevention of MI-induced HF
Acronym
PREVENT-TAHA
Official Title
Transplantation of Mesenchymal Stem Cells for Prevention of Acute Myocardial Infarction Induced Heart Failure: A Phase III Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
Collaborators
National Institute of Medical Research Development (NIMAD), Iran, Cell Tech Pharmed Company, Iran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Results from recent clinical trials on bone marrow mononuclear cell (BM-MNC) transplantation show that this intervention can help reduce the incidence of heart failure (HF) after acute myocardial infarction (AMI). However, no study has evaluated the effect of the transplantation of mesenchymal stem cells (MSCs) on a clinical endpoint such as HF. This single-blinded, randomized, multicenter trial aims to establish whether the intracoronary infusion of umbilical cord-derived Wharton's jelly MSCs (WJ-MSCs) helps prevent HF development after AMI. The study will enroll 240 patients 3 to 7 days following an AMI treated with primary percutaenous coronary intervention (PPCI). Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. They will be randomized to receive either a single intracoronary infusion of WJ-MSCs or standard care. The primary outcome of this study is the assessment of HF development during long-term follow-up (four years). Since the efficacy of MSCs is higher than BM-MNCs after AMI in the improvement of LVEF, it would be probable that these cells may have a better clinical effect as well. However, no study has evaluated the impact of the transplantation of MSCs on a clinical endpoint such as HF. This study will help determine whether or not the infusion of intracoronary WJ-MSCs in patients
Detailed Description
A randomized, multicenter, single-blinded phase III trial will be conducted to assess whether the intracoronary infusion of umbilical cord WJ-MSCs demonstrates a superior effect in reducing HF incidence following AMIs compared to standard treatment. The sample size was determined with a 5% error, 80% power, a one-year HF incidence rate of 1.3-4%, and division between two groups in a 2:1 ratio (control:intervention), and a three-year follow-up period. A total of 360 patients with a history of an anterior ST-elevation MI (STEMI) successfully reperfused within standard golden time within 3-7 days after AMI will be enrolled. Randomization will be done via permuted block randomization through a web-based service. A block size of 4 will be considered. Two groups of equal proportion will be formed, where only one will receive an intracoronary infusion of WJ-MSCs besides the conventional therapy provided to both groups. Those who assess the study outcomes will remain unaware of the allocation (single-blind). This study will use cGMP-certified clinical-grade human WJ-MSCs (Cell Tech Pharmed Co. Ltd., Tehran, Iran).In the intervention group, all 120 patients will receive a single intracoronary infusion of 107 WJ-MSCs alongside the conventional treatment that will be provided to the same number of patients in the control group. Patients in the intervention group will be taken to the cardiac catheterization lab, where the infusion of 107 WJ-MSCs will be done through the intracoronary route. Before statistical analysis, adjudication of all measurements will be done by an experienced cardiology department member excluded from the research group. The adjudicator will assess the quality of each measurement and will exclude those with inadequate quality from the analysis, where they will be regarded as missing. An independent, blinded safety committee will evaluate potential major adverse cardiac events (MACEs). Once the adjudication process is complete, the finalized database will be unblinded. Data will be kept anonymous until analysis, which is to be performed by an independent statistician external to the research group. Treatment efficacy will be assessed according to the decrement in HF with the help of Cox regression analysis. The investigators will consider the EF to have improved significantly if a minimum increment of 3% is achieved after six months. The analysis will follow the intention-to-treat approach. The baseline characteristics of the two study groups will also be compared. Continuous variables will be summarized using the mean and standard deviation, while frequencies and percentages will be given for categorical data. The EF, as the primary outcome, will be compared between the study groups using the independent t-test and one-way analysis of variance (ANOVA). The therapeutic effect will be estimated with a 95% CI. Two-sided P-values will be used. Safety will be compared between the two groups according to the occurrence of MACEs (death, recurrent AMI, ICD insertion, non-target vessel revascularization, etc.) and serious adverse events (SAEs). These events will be followed over time with Kaplan-Meier curves, which will allow us to understand their patterns. With the help of the Cox proportional hazards model, The investigators will assess the statistical significance and 95% CI. Data will be kept anonymous until analysis, which is to be performed by an independent statistician external to the research group. Treatment efficacy will be assessed according to the decrement in HF with the help of Cox regression analysis. The investigators will consider the EF to have improved significantly if a minimum increment of 3% is achieved after six months. The analysis will follow the intention-to-treat approach. The baseline characteristics of the two study groups will also be compared. Continuous variables will be summarized using the mean and standard deviation, while frequencies and percentages will be given for categorical data. The EF, as the primary outcome, will be compared between the study groups using the independent t-test and one-way analysis of variance (ANOVA). The therapeutic effect will be estimated with a 95% CI. Two-sided P-values will be used. Safety will be compared between the two groups according to the occurrence of MACEs (death, recurrent AMI, ICD insertion, non-target vessel revascularization, etc.) and serious adverse events (SAEs). These events will be followed over time with Kaplan-Meier curves, which will allow us to understand their patterns. With the help of the Cox proportional hazards model, The investigators will assess the statistical significance and 95% CI. Adverse events will be reported by the study's executive committee to an independent Data and Safety and Monitoring Board (DSMB). The DSMB will have the authority to stop the trial early if patient safety is compromised or if the primary research objective is met. All safety issues (unanticipated SAEs, mortality, intracoronary infusion complications, and severe arrhythmias, etc.) will be monitored by the DSMB, and the DSMB statistician will report the occurrence of safety issues in each study group quarterly. All deaths will be reported. The investigators have discussed all ethical issues with the Institutional Review Board of Shiraz University of Medical Sciences, which ultimately approved the study protocol (IR.SUMS.REC.1400.409). Informed consent will be obtained once patients are clinically stable and sedatives or strong analgesics do not alter their consciousness. Importantly, the use of low balloon inflation pressure and divided (three-part) infusions will prevent complications related to intracoronary cell infusion. The principles of the Declaration of Helsinki will be upheld throughout this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute, Myocardial Infarction First, Myocardial Infarction, Anterior Wall, Cardiac Remodeling, Ventricular, STEMI, Regenerative Medicine, Heart Failure
Keywords
WJ-MSCs, Myocardial infarction, Heart failure, Regenerative medicine, Tissue therapy, Stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A single-blinded, randomized, multicenter trial.
Masking
Outcomes Assessor
Masking Description
Single-blinded
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
In the experimental group, 3-7 days after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive a single intracoronary infusion of 10^7 umbilical cord-derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) alongside conventional treatment.
Arm Title
Cohort 2 (Control Group)
Arm Type
Active Comparator
Arm Description
In the control group, after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive only conventional treatment.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs)
Intervention Description
Cell Tech Pharmed Company (Tehran, Iran) will provide us with cGMP grade WJ-MSCs. 10^7 WJ-MSCs will be delivered through the intracoronary route. WJ-MSCs will be infused at a rate of 2.5 ml/min across three portions.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
Beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, aldosterone antagonist, aspirin, ticagrelor, statin, and glyceryl trinitrate plus cardiac rehabilitation.
Primary Outcome Measure Information:
Title
Incidence of Heart Failure
Description
The incidence of heart failure during the follow-up period.
Time Frame
Checked at three years
Secondary Outcome Measure Information:
Title
Change in Left Ventricular Function from base line
Description
Measurement of left ventricular function with echocardiography
Time Frame
At baseline and after six months
Title
Cardiovascular Death
Description
Occurrence of mortality due to cardiovascular causes
Time Frame
Checked at three years
Title
Composite outcome of cardiovascular death and heart failure incidence
Description
Occurrence of mortality due to cardiovascular causes or heart failure
Time Frame
Checked at three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years Either gender First myocardial infarction in the preceding 3 to 7 days Post-acute myocardial infarction left ventricular ejection fraction < 40% Negative pregnancy test (for women of reproductive age) Written informed consent Exclusion Criteria: A history of any prior cardiac conditions (valvular, ischemic, or congenital disorders) Regional wall motion abnormalities outside the region of the infarction LV dysfunction due to other etiologies like non-ischemic cardiomyopathy, anthracycline use, or ethanol abuse (> 6 oz./day regularly) Poor echocardiography window Active infection, malignancy, or autoimmune disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armin Attar, MD
Phone
9177141797
Ext
+98
Email
attarar@sums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Attar, MD
Organizational Affiliation
Department of Cardiovascular Medicine, TAHA clinical trial group, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Al-Zahra Heart Hospital, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Attar, MD
Phone
+989177141797
Email
attarar@sums.ac.ir
Facility Name
Faghihi Hospital
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javad Kojouri, MD
Facility Name
Namazee Hospital
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peyman Izadpanah, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to publish the study protocol soon. The final results will be published in the form of an article after the study is completed.
IPD Sharing Time Frame
The study protocol will be submitted for publishing within six months.
IPD Sharing Access Criteria
Supporting data will be made available upon reasonable request. All inquiries should be sent to the study director, Dr. Armin Attar.
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MSCs for Prevention of MI-induced HF

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