NCT03902067

Brief Summary

A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
5.7 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 25, 2024

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

March 28, 2019

Last Update Submit

April 24, 2024

Conditions

Left Ventricular DysfunctionAcute Myocardial Infarction

Keywords

AMI

Outcome Measures

Primary Outcomes (1)

  • Safety measured as the number of Major Adverse Cardiac Events (MACE)

    Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc.

    12 months

Secondary Outcomes (1)

  • Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up

    12 months

Study Arms (2)

UC-MSC

EXPERIMENTAL

UC-MSC transplantation

Biological: UC-MSC

Control Group

PLACEBO COMPARATOR

Routine treatment

Biological: Control Group

Interventions

UC-MSCBIOLOGICAL

0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability\>80%, and endotoxin\<0.1 EU， at the concentration of 2x10(7) cells/ml.

Also known as: Transplantation Group
UC-MSC
Control GroupBIOLOGICAL

Routine treatment without catheter infusion

Control Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.
  • Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;
  • Good compliance, willing to take drugs and follow up according to the requirements of the plan;
  • Life expectancy exceeds one year.

You may not qualify if:

  • Those who cannot tolerate cell therapy;
  • Patients with severe hepatic and renal insufficiency (ALT\>1.5 times the upper limit of normal value, Cr \>1.5 times the upper limit of normal value);
  • Patients with malignant tumors or extremely weak patients;
  • Patients with severe infection;
  • Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;
  • Patients with other serious systemic diseases and organ dysfunction;
  • Patients with cardiogenic shock;
  • Patients with hemorrhagic diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Chengxing Shen, Dr.

    Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengxing Shen

CONTACT

+86-18501664545shencx@sjtu.edu.cn

Gang LU

CONTACT

+862134712825glu@shlifestemcell.com

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

March 28, 2019

First Posted

April 3, 2019

Study Start

December 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 25, 2024

Record last verified: 2023-10

Locations

CN(1)