NCT04340609

Brief Summary

The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

2.1 years

First QC Date

February 8, 2020

Last Update Submit

June 12, 2022

Conditions

Acute Myocardial Infarction

Keywords

Allogeneic Mesenchymal Stem CellsUmbilical Cord Mesenchymal Stem CellsIntravenous Mesenchymal Stem CellsIntracoronary Mesenechymal Stem Cells

Outcome Measures

Primary Outcomes (16)

  • Major adverse cardiac events (MACE) endpoints of mortality

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    2 weeks after stem cell

  • Major adverse cardiac events (MACE) endpoints of mortality

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    3 months after stem cell

  • Major adverse cardiac events (MACE) endpoints of mortality

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    6 months after stem cell

  • Major adverse cardiac events (MACE) endpoints of mortality

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    12 months after stem cell

  • Re-infarction

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    2 weeks after stem cell

  • Re-infarction

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    3 months after stem cell

  • Re-infarction

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    6 months after stem cell

  • Re-infarction

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    12 months after stem cell

  • Target vessel revascularization (TVR)

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    2 weeks after stem cell

  • Target vessel revascularization (TVR)

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    3 months after stem cell

  • Target vessel revascularization (TVR)

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    6 months after stem cell

  • Target vessel revascularization (TVR)

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    12 months after stem cell

  • Heart failure hospitalization

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    2 weeks after stem cell

  • Heart failure hospitalization

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    3 months after stem cell

  • Heart failure hospitalization

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    6 months after stem cell

  • Heart failure hospitalization

    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

    12 months after stem cell

Secondary Outcomes (9)

  • Cardiac MRI

    6 months after stem cell

  • Cardiac MRI

    12 months after stem cell

  • Echocardiography

    6 months after stem cell

  • Echocardiography

    12 months after stem cell

  • Electrocardiography (ECG)

    3 months after stem cell

  • +4 more secondary outcomes

Study Arms (3)

Intravenous Group

EXPERIMENTAL

Dosage of intravenous route is 2 million MSCs/kg for each subject.

Biological: Mesenchymal Stem Cells

Intracoronary Group

EXPERIMENTAL

Dosage of intracoronary route is ±50 million MSCs for each subject.

Biological: Mesenchymal Stem Cells

Control Group

NO INTERVENTION

Standard treatment of acute myocardia infarction

Interventions

Mesenchymal Stem CellsBIOLOGICAL

The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.

Intracoronary GroupIntravenous Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
  • Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of \< 45% by echocardiography.
  • Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf,
  • Willingness to attend all scheduled safety follow-up visits
  • Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF \<45).

You may not qualify if:

  • Hemodynamic instability as demonstrated by any of the following,
  • Requirement of intra-aortic balloon pump of left ventricular assist device,
  • Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg,
  • Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb \< 10 g/dL, WBC \< 4 or \> 11x109/L, or platelets \< 100x109/L), kidney failure (creatinine level \> 2.5 mg/dL, or creatinine clearance \< 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
  • Prosthetic valves,
  • Hypertrophic or restrictive cardiomyopathy,
  • Women of child-bearing potential,
  • Inability to comply with the protocol,
  • Currently using implantable electronic defibrillator or pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PT Prodia StemCell Indonesia

Jakarta, Indonesia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2020

First Posted

April 9, 2020

Study Start

March 11, 2019

Primary Completion

April 8, 2021

Study Completion

April 8, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations

ID(1)