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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bone marrow mesenchymal stem cells transfer
Best medical treatment
Percutaneous coronary intervention
Sponsored by
Affiliated Hospital of North Sichuan Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Mesenchymal stem cells, Bone marrow, Stem cells transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Third Hospital of Mianyang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

BM-MSCs group

Control group

Arm Description

Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )

Receive the best medication, percutaneous coronary intervention

Outcomes

Primary Outcome Measures

changes in myocardial metabolic activity
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Changes in left ventricular ejection fraction (LVEF)
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.

Secondary Outcome Measures

incidence of cardiovascular events
incidence of cardiovascular events
overall mortality
overall mortality
adverse events at 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs

Full Information

First Posted
May 14, 2020
Last Updated
June 5, 2020
Sponsor
Affiliated Hospital of North Sichuan Medical College
Collaborators
Chinese PLA General Hospital, Peking Union Medical College Hospital, Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04421274
Brief Title
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction
Acronym
Bmmsct
Official Title
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2008 (Actual)
Primary Completion Date
July 10, 2010 (Actual)
Study Completion Date
July 15, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of North Sichuan Medical College
Collaborators
Chinese PLA General Hospital, Peking Union Medical College Hospital, Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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） .
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Mesenchymal stem cells, Bone marrow, Stem cells transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BM-MSCs group
Arm Type
Experimental
Arm Description
Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Receive the best medication, percutaneous coronary intervention
Intervention Type
Biological
Intervention Name(s)
Bone marrow mesenchymal stem cells transfer
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Best medical treatment
Intervention Description
Refer to the latest medication guidelines and give the best medication to the patients
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
changes in myocardial metabolic activity
Description
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Time Frame
Baseline + after 6 months
Title
Changes in left ventricular ejection fraction (LVEF)
Description
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
Time Frame
Baseline + after 12 months
Secondary Outcome Measure Information:
Title
incidence of cardiovascular events
Description
incidence of cardiovascular events
Time Frame
in 12 months after transplantation of autologous BM-MSCs
Title
overall mortality
Description
overall mortality
Time Frame
in 12 months after transplantation of autologous BM-MSCs
Title
adverse events at 12 months after transplantation of autologous BM-MSCs
Description
adverse events at 12 months after transplantation of autologous BM-MSCs
Time Frame
in 12 months after transplantation of autologous BM-MSCs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Third Hospital of Mianyang
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
0816
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Unfortunately, the research data is not shared
Citations:
PubMed Identifier
33413636
Citation
Zhang R, Yu J, Zhang N, Li W, Wang J, Cai G, Chen Y, Yang Y, Liu Z. Bone marrow mesenchymal stem cells transfer in patients with ST-segment elevation myocardial infarction: single-blind, multicenter, randomized controlled trial. Stem Cell Res Ther. 2021 Jan 7;12(1):33. doi: 10.1186/s13287-020-02096-6.
Results Reference
derived

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

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