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

NCT ID: NCT04421274

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-01

Study Completion Date

2011-07-15

Brief Summary

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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

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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).

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BM-MSCs group

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

Group Type EXPERIMENTAL

Bone marrow mesenchymal stem cells transfer

Intervention Type BIOLOGICAL

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

Best medical treatment

Intervention Type DRUG

Refer to the latest medication guidelines and give the best medication to the patients

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Control group

Receive the best medication, percutaneous coronary intervention

Group Type SHAM_COMPARATOR

Best medical treatment

Intervention Type DRUG

Refer to the latest medication guidelines and give the best medication to the patients

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Interventions

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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

Intervention Type BIOLOGICAL

Best medical treatment

Refer to the latest medication guidelines and give the best medication to the patients

Intervention Type DRUG

Percutaneous coronary intervention

Percutaneous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Third Hospital of Mianyang

Mianyang, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33413636 (View on PubMed)

Other Identifiers

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ScPHFPC-100306

Identifier Type: -

Identifier Source: org_study_id

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