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Completed

NCT Number: NCT04421274

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

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) .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Third Hospital of Mianyang

Mianyang, Sichuan, 0816, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow mesenchymal stem cells transfer

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

Drug

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

Percutaneous coronary intervention

Procedure

Percutaneous coronary intervention

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. incidence of cardiovascular events

    Time frame: in 12 months after transplantation of autologous BM-MSCs

    incidence of cardiovascular events

  2. overall mortality

    Time frame: in 12 months after transplantation of autologous BM-MSCs

    overall mortality

  3. 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

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of North Sichuan Medical College

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Bmmsct

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jun 9, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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