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

NCT04421274 | Completed Phase 2

• 1 other identifier: ScPHFPC-100306
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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） .

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Mesenchymal stem cells; Bone marrow; Stem cells transplantation

Outcome Measures

Primary Outcomes (2)

• changes in myocardial metabolic activity

  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)

  Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.

  Baseline + after 12 months

Secondary Outcomes (3)

• incidence of cardiovascular events

  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

  in 12 months after transplantation of autologous BM-MSCs

Study Arms (2)

BM-MSCs group

EXPERIMENTAL

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

Biological: Bone marrow mesenchymal stem cells transfer; Drug: Best medical treatment; Procedure: Percutaneous coronary intervention

Control group

SHAM COMPARATOR

Receive the best medication, percutaneous coronary intervention

Drug: Best medical treatment; Procedure: Percutaneous coronary intervention

Interventions

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

BM-MSCs group

Best medical treatment DRUG

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

BM-MSCs group; Control group

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention

BM-MSCs group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of North Sichuan Medical College: lead
• Chinese PLA General Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Beijing Tongren Hospital: collaborator

Study Sites (1)

The Third Hospital of Mianyang

Mianyang, Sichuan, 0816, China

Location

Related Publications (1)

• 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.

  PMID: 33413636 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 9, 2020
• Study Start: May 1, 2008
• Primary Completion: July 10, 2010
• Study Completion: July 15, 2011
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)