Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction (Bmmsct)

June 5, 2020 updated by: Affiliated Hospital of North Sichuan Medical College

Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial

To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. We plan to include approximately 40 patients with ST-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were randomly divided into a BM-MSCs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of adverse events. The above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (SPECT).

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Mianyang, Sichuan, China, 0816
        • The Third Hospital of Mianyang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age> 18 years old;
  • Diagnosed acute ST-elevation myocardial infarction (STEMI)
  • STEMI onset <1 month
  • Successful vascular remodeling, blood flow of infarct-related blood vessels recovered to TIMI level 3
  • All patients included in the study signed an informed consent form and promised to complete all follow-up plans

Exclusion Criteria:

  • Refractory persistent ventricular tachycardia
  • High cardiac block and no pacemaker control
  • Liver or renal dysfunction (ALT>80U/ L, Cr> 440mmol / L)
  • Bleeding disorders, malignant tumors
  • Autoimmune disease or any serious fatal disease
  • Contraindications for coronary intervention
  • Combined with other heart disease: congenital heart Disease (ventricular deficiency, atrial deficient, patent ductus arteriosus and other congenital alformations),primary valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous edema heart disease and so on
  • Mental illness, no self-awareness, and no precise expression and cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BM-MSCs group
Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Biological: Bone marrow mesenchymal stem cells transfer
Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times
Drug: Best medical treatment
Refer to the latest medication guidelines and give the best medication to the patients
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention
SHAM_COMPARATOR: Control group
Receive the best medication, percutaneous coronary intervention
Drug: Best medical treatment
Refer to the latest medication guidelines and give the best medication to the patients
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in myocardial metabolic activity
Time Frame: Baseline + after 6 months
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Baseline + after 6 months
Changes in left ventricular ejection fraction (LVEF)
Time Frame: Baseline + after 12 months
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
Baseline + after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of cardiovascular events
Time Frame: in 12 months after transplantation of autologous BM-MSCs
incidence of cardiovascular events
in 12 months after transplantation of autologous BM-MSCs
overall mortality
Time Frame: in 12 months after transplantation of autologous BM-MSCs
overall mortality
in 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs
Time Frame: in 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs
in 12 months after transplantation of autologous BM-MSCs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of North Sichuan Medical College

Collaborators

Peking Union Medical College Hospital
Chinese PLA General Hospital
Beijing Tongren Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2008

Primary Completion (ACTUAL)

July 10, 2010

Study Completion (ACTUAL)

July 15, 2011

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 5, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ScPHFPC-100306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Unfortunately, the research data is not shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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