Myocardial Infarction, AcutePhase 3PREVENT-TAHA8NCT05043610
MSCs for Prevention of MI-induced HF
A Phase 3 study testing Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) and Conventional Treatment in people with Myocardial Infarction, Acute and Myocardial Infarction First, run by Shiraz University of Medical Sciences at 3 sites in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myocardial Infarction, Acute, Myocardial Infarction First, Myocardial Infarction, Anterior Wall
- What is being tested?
- Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) and Conventional Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 3 sitesIran
- Study dates
- 15 Sep 2021to 1 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Iran3 sites
Al-Zahra Heart Hospital, Shiraz University of Medical Sciences
Shiraz, Fars
Faghihi Hospital
Shiraz, Fars
Namazee Hospital
Shiraz, Fars
About this study
Official title: Transplantation of Mesenchymal Stem Cells for Prevention of Acute Myocardial Infarction Induced Heart Failure: a Phase III Randomized Clinical Trial
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 percutaneous coronary intervention (PPCI). Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. Patients 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 (three 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 AMI patients with impaired LVEF would prevent HF development and future adverse events.
Read the 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. In the intervention group, all 120 patients will receive a single intracoronary infusion of 10^7 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 10^7 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 patients with inadequate quality from the analysis, where participants 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.
- Conditions
- Myocardial Infarction, Acute, Myocardial Infarction First, Myocardial Infarction, Anterior Wall, Cardiac Remodeling, Ventricular, STEMI, Regenerative Medicine
- Being tested
- Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs), Conventional Treatment
- Keywords
- WJ-MSCs, Myocardial infarction, Heart failure, Regenerative medicine, Tissue therapy, Stem cell therapy
- Medical subject headings
- Myocardial Infarction, Anterior Wall Myocardial Infarction, Ventricular Remodeling, ST Elevation Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs)Biological
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.
Conventional TreatmentOther
Beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, aldosterone antagonist, aspirin, ticagrelor, statin, and glyceryl trinitrate plus cardiac rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| WJ-MSCs intracoronary infusion + standard care | Experimental | 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. Receives: Biological: Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs); Other: Conventional Treatment |
| standard care (Control Group) | Active comparator | In the control group, after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 240 patients will receive only conventional treatment. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Heart Failure
The incidence of heart failure during the follow-up period.
Measured: Checked at three years
Secondary outcomes (3)
Change in Left Ventricular Function from base line
Measurement of left ventricular function with echocardiography
Measured: At baseline and after six months
Cardiovascular Death
Occurrence of mortality due to cardiovascular causes
Measured: Checked at three years
Composite outcome of cardiovascular death and heart failure incidence
Occurrence of mortality due to cardiovascular causes or heart failure
Measured: Checked at three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start15 Sep 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blinded, randomized, multicenter trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research and Development
- Responsible party
- Principal investigator, Armin Attar, Shiraz University of Medical Sciences
- Investigators
- Armin Attar, MD, Study director, Department of Cardiovascular Medicine, TAHA clinical trial group, Shiraz University of Medical Sciences, Shiraz, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043610
- Sponsor's protocol ID
- IR.SUMS.REC.1400.409
- Acronym
- PREVENT-TAHA8
- Status last verified
- Oct 2024
- First submitted
- 29 Aug 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators published the study protocol. The final results will be published in the form of an article soon.
Publications
Attar A, Monabati A, Montaseri M, Vosough M, Hosseini SA, Kojouri J, Abdi-Ardekani A, Izadpanah P, Azarpira N, Pouladfar G, Ramzi M. Transplantation of mesenchymal stem cells for prevention of acute myocardial infarction induced heart failure: study protocol of a phase III randomized clinical trial (Prevent-TAHA8). Trials. 2022 Aug 4;23(1):632. doi: 10.1186/s13063-022-06594-1.
PubMed 35927674Velagaleti RS, Pencina MJ, Murabito JM, Wang TJ, Parikh NI, D'Agostino RB, Levy D, Kannel WB, Vasan RS. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation. 2008 Nov 11;118(20):2057-62. doi: 10.1161/CIRCULATIONAHA.108.784215. Epub 2008 Oct 27.
PubMed 18955667Hellermann JP, Jacobsen SJ, Gersh BJ, Rodeheffer RJ, Reeder GS, Roger VL. Heart failure after myocardial infarction: a review. Am J Med. 2002 Sep;113(4):324-30. doi: 10.1016/s0002-9343(02)01185-3.
PubMed 12361819Lewis EF, Moye LA, Rouleau JL, Sacks FM, Arnold JM, Warnica JW, Flaker GC, Braunwald E, Pfeffer MA; CARE Study. Predictors of late development of heart failure in stable survivors of myocardial infarction: the CARE study. J Am Coll Cardiol. 2003 Oct 15;42(8):1446-53. doi: 10.1016/s0735-1097(03)01057-x.
PubMed 14563590Juilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.
PubMed 22357361Braunwald E. Cell-Based Therapy in Cardiac Regeneration: An Overview. Circ Res. 2018 Jul 6;123(2):132-137. doi: 10.1161/CIRCRESAHA.118.313484. No abstract available.
PubMed 29976683Taylor DA, Atkins BZ, Hungspreugs P, Jones TR, Reedy MC, Hutcheson KA, Glower DD, Kraus WE. Regenerating functional myocardium: improved performance after skeletal myoblast transplantation. Nat Med. 1998 Aug;4(8):929-33. doi: 10.1038/nm0898-929.
PubMed 9701245Kocher AA, Schuster MD, Szabolcs MJ, Takuma S, Burkhoff D, Wang J, Homma S, Edwards NM, Itescu S. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med. 2001 Apr;7(4):430-6. doi: 10.1038/86498.
PubMed 11283669Williams AR, Hare JM. Mesenchymal stem cells: biology, pathophysiology, translational findings, and therapeutic implications for cardiac disease. Circ Res. 2011 Sep 30;109(8):923-40. doi: 10.1161/CIRCRESAHA.111.243147.
PubMed 21960725Houtgraaf JH, den Dekker WK, van Dalen BM, Springeling T, de Jong R, van Geuns RJ, Geleijnse ML, Fernandez-Aviles F, Zijlsta F, Serruys PW, Duckers HJ. First experience in humans using adipose tissue-derived regenerative cells in the treatment of patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2012 Jan 31;59(5):539-40. doi: 10.1016/j.jacc.2011.09.065. No abstract available.
PubMed 22281257Jeong H, Yim HW, Park HJ, Cho Y, Hong H, Kim NJ, Oh IH. Mesenchymal Stem Cell Therapy for Ischemic Heart Disease: Systematic Review and Meta-analysis. Int J Stem Cells. 2018 May 30;11(1):1-12. doi: 10.15283/ijsc17061.
PubMed 29482311Gao LR, Chen Y, Zhang NK, Yang XL, Liu HL, Wang ZG, Yan XY, Wang Y, Zhu ZM, Li TC, Wang LH, Chen HY, Chen YD, Huang CL, Qu P, Yao C, Wang B, Chen GH, Wang ZM, Xu ZY, Bai J, Lu D, Shen YH, Guo F, Liu MY, Yang Y, Ding YC, Yang Y, Tian HT, Ding QA, Li LN, Yang XC, Hu X. Intracoronary infusion of Wharton's jelly-derived mesenchymal stem cells in acute myocardial infarction: double-blind, randomized controlled trial. BMC Med. 2015 Jul 10;13:162. doi: 10.1186/s12916-015-0399-z.
PubMed 26162993Attar A, Mirhosseini SA, Mathur A, Dowlut S, Monabati A, Kasaei M, Abtahi F, Kiwan Y, Vosough M, Azarpira N. Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8). BMJ. 2025 Oct 29;391:e083382. doi: 10.1136/bmj-2024-083382.
PubMed 41224473
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Mesenchymal Stem Cells for Prevention of Acute Myocardial Infarction Induced Heart Failure: a Phase III Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05043610
- Acronym / sponsor ID
- PREVENT-TAHA8 / IR.SUMS.REC.1400.409
- Conditions
- Myocardial Infarction, Acute, Myocardial Infarction First, Myocardial Infarction, Anterior Wall, Cardiac Remodeling, Ventricular, STEMI, Regenerative Medicine
- Keywords
- WJ-MSCs, Myocardial infarction, Heart failure, Regenerative medicine, Tissue therapy, Stem cell therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- National Institute for Medical Research and Development
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 percutaneous coronary intervention (PPCI). Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. Patients 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 (three 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 AMI patients with impaired LVEF would prevent HF development and future adverse events.
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. In the intervention group, all 120 patients will receive a single intracoronary infusion of 10^7 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 10^7 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 patients with inadequate quality from the analysis, where participants 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blinded, randomized, multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| WJ-MSCs intracoronary infusion + standard care | Experimental | Biological: Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs), Other: Conventional TreatmentIn 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. |
| standard care (Control Group) | Active comparator | Other: Conventional TreatmentIn the control group, after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 240 patients will receive only conventional treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs)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. | Biological | WJ-MSCs intracoronary infusion + standard care |
| Conventional TreatmentBeta-blocker, angiotensin-converting enzyme (ACE) inhibitor, aldosterone antagonist, aspirin, ticagrelor, statin, and glyceryl trinitrate plus cardiac rehabilitation. | Other | WJ-MSCs intracoronary infusion + standard care, standard care (Control Group) |
Primary outcome
Incidence of Heart Failure
Time frame: Checked at three years
The incidence of heart failure during the follow-up period.
3 secondary outcomes
Change in Left Ventricular Function from base line
Time frame: At baseline and after six months
Cardiovascular Death
Time frame: Checked at three years
Composite outcome of cardiovascular death and heart failure incidence
Time frame: Checked at three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 35927674Attar A, Monabati A, Montaseri M, Vosough M, Hosseini SA, Kojouri J, Abdi-Ardekani A, Izadpanah P, Azarpira N, Pouladfar G, Ramzi M. Transplantation of mesenchymal stem cells for prevention of acute myocardial infarction induced heart failure: study protocol of a phase III randomized clinical trial (Prevent-TAHA8). Trials. 2022 Aug 4;23(1):632. doi: 10.1186/s13063-022-06594-1.
- Background: PubMed 18955667Velagaleti RS, Pencina MJ, Murabito JM, Wang TJ, Parikh NI, D'Agostino RB, Levy D, Kannel WB, Vasan RS. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation. 2008 Nov 11;118(20):2057-62. doi: 10.1161/CIRCULATIONAHA.108.784215. Epub 2008 Oct 27.
- Background: PubMed 12361819Hellermann JP, Jacobsen SJ, Gersh BJ, Rodeheffer RJ, Reeder GS, Roger VL. Heart failure after myocardial infarction: a review. Am J Med. 2002 Sep;113(4):324-30. doi: 10.1016/s0002-9343(02)01185-3.
- Background: PubMed 14563590Lewis EF, Moye LA, Rouleau JL, Sacks FM, Arnold JM, Warnica JW, Flaker GC, Braunwald E, Pfeffer MA; CARE Study. Predictors of late development of heart failure in stable survivors of myocardial infarction: the CARE study. J Am Coll Cardiol. 2003 Oct 15;42(8):1446-53. doi: 10.1016/s0735-1097(03)01057-x.
- Background: PubMed 22357361Juilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.
- Background: PubMed 29976683Braunwald E. Cell-Based Therapy in Cardiac Regeneration: An Overview. Circ Res. 2018 Jul 6;123(2):132-137. doi: 10.1161/CIRCRESAHA.118.313484. No abstract available.
- Background: PubMed 9701245Taylor DA, Atkins BZ, Hungspreugs P, Jones TR, Reedy MC, Hutcheson KA, Glower DD, Kraus WE. Regenerating functional myocardium: improved performance after skeletal myoblast transplantation. Nat Med. 1998 Aug;4(8):929-33. doi: 10.1038/nm0898-929.
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- Individual participant dataSharing planned: Yes. Investigators published the study protocol. The final results will be published in the form of an article soon.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Attar, MD study director
Department of Cardiovascular Medicine, TAHA clinical trial group, Shiraz University of Medical Sciences, Shiraz, Iran
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) and Conventional Treatment in people with Myocardial Infarction, Acute and Myocardial Infarction First, run by Shiraz University of Medical Sciences at 3 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Heart Failure (time frame: Checked at three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043610, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.