Clinical trial NCT04421274: Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Mesenchymal stem cells
Bone marrow
Stem cells transplantation
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical College
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Peking Union Medical College Hospital
name: Beijing Tongren Hospital
First posted: 2020-06-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: changes in myocardial metabolic activity
timeFrame: Baseline + after 6 months
measure: Changes in left ventricular ejection fraction (LVEF)
timeFrame: Baseline + after 12 months
Secondary outcomes:
measure: incidence of cardiovascular events
timeFrame: in 12 months after transplantation of autologous BM-MSCs
measure: overall mortality
timeFrame: in 12 months after transplantation of autologous BM-MSCs
measure: adverse events at 12 months after transplantation of autologous BM-MSCs
timeFrame: in 12 months after transplantation of autologous BM-MSCs
Other outcomes:
Locations:
city: Mianyang
country: China
facility: The Third Hospital of Mianyang
state: Sichuan
Study officials:
References:
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.