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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05043610
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
National Institute of Medical Research Development (NIMAD), Iran
Cell Tech Pharmed Company, Iran
Information provided by (Responsible Party):
Armin Attar, Shiraz University of Medical Sciences

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


Condition or disease Intervention/treatment Phase
Myocardial Infarction, Acute Myocardial Infarction First Myocardial Infarction, Anterior Wall Cardiac Remodeling, Ventricular STEMI Regenerative Medicine Heart Failure Biological: Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) Other: Conventional Treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single-blinded, randomized, multicenter trial.
Masking: Single (Outcomes Assessor)
Masking Description: Single-blinded
Primary Purpose: Treatment
Official Title: Transplantation of Mesenchymal Stem Cells for Prevention of Acute Myocardial Infarction Induced Heart Failure: A Phase III Randomized Clinical Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
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.
Biological: Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs)
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.

Other: Conventional Treatment
Beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, aldosterone antagonist, aspirin, ticagrelor, statin, and glyceryl trinitrate plus cardiac rehabilitation.

Active Comparator: Cohort 2 (Control Group)
In the control group, after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive only conventional treatment.
Other: Conventional Treatment
Beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, aldosterone antagonist, aspirin, ticagrelor, statin, and glyceryl trinitrate plus cardiac rehabilitation.




Primary Outcome Measures :
  1. Incidence of Heart Failure [ Time Frame: Checked at three years ]
    The incidence of heart failure during the follow-up period.


Secondary Outcome Measures :
  1. Change in Left Ventricular Function from base line [ Time Frame: At baseline and after six months ]
    Measurement of left ventricular function with echocardiography

  2. Cardiovascular Death [ Time Frame: Checked at three years ]
    Occurrence of mortality due to cardiovascular causes

  3. Composite outcome of cardiovascular death and heart failure incidence [ Time Frame: Checked at three years ]
    Occurrence of mortality due to cardiovascular causes or heart failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043610


Contacts
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Contact: Armin Attar, MD 9177141797 ext +98 attarar@sums.ac.ir

Locations
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Iran, Islamic Republic of
Al-Zahra Heart Hospital, Shiraz University of Medical Sciences Recruiting
Shiraz, Fars, Iran, Islamic Republic of
Contact: Armin Attar, MD    +989177141797    attarar@sums.ac.ir   
Faghihi Hospital Recruiting
Shiraz, Fars, Iran, Islamic Republic of
Contact: Javad Kojouri, MD         
Namazee Hospital Recruiting
Shiraz, Fars, Iran, Islamic Republic of
Contact: Peyman Izadpanah, MD         
Sponsors and Collaborators
Shiraz University of Medical Sciences
National Institute of Medical Research Development (NIMAD), Iran
Cell Tech Pharmed Company, Iran
Investigators
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Study Director: Armin Attar, MD Department of Cardiovascular Medicine, TAHA clinical trial group, Shiraz University of Medical Sciences, Shiraz, Iran
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Armin Attar, Director of cardiovascular regeneration and genetics program, and cardiovascular diseases' registries, Principal Investigator, Clinical Professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT05043610    
Other Study ID Numbers: IR.SUMS.REC.1400.409
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: The study protocol will be submitted for publishing within six months.
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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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
Keywords provided by Armin Attar, Shiraz University of Medical Sciences:
WJ-MSCs
Myocardial infarction
Heart failure
Regenerative medicine
Tissue therapy
Stem cell therapy
Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Anterior Wall Myocardial Infarction
Infarction
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Pathological Conditions, Anatomical