Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI)

ST-Elevation Myocardial Infarction Clinical Trial

— WJ-MSC-AMI  

Official title:

Phase 2 Study of Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With ST-segment Elevation Acute Myocardial Infarction (AMI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291329
• Other study ID #: 2006AA02Z469
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2011
• Last updated: February 12, 2015
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2015
• Source: Navy General Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of intracoronary human umbilical Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) transfer in patients with ST-segment elevation acute myocardial infarction.

Description:

It has been demonstrated that MSCs have the potential to differentiate into cardiomyocytes both in vitro and in vivo. Several clinical trials have been performed using autologous bone marrow-derived MSCs, but the results of these trials have been unsatisfactory because of a low number of MSCs in older patients and in those with coronary heart disease. WJ-MSCs from the human umbilical cord matrix which are of epiblastic origin and contain both human embryonic stem cell (hESC) and human mesenchymal stem cell markers appear to have a number of important advantages: they do not raise ethical issues, are widely multipotent, are not tumorigenic, and are not immunogenetic. Because of a short population doubling time they can be rapidly scaled up in large numbers. We performed a double-blind, placebo-controlled, multicenter trial, randomly assigning 160 patients with acute ST-segment elevation myocardial infarction to receive an intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients at least 18 years of age;

2. Patients with 1st acute ST-elevation myocardial infarction (AMI) who undergo successful primary percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade 3, but have a substantial residual left ventricular regional wall-motion abnormality measured by 2-D echocardiography.

3. No contraindications to undergoing cell-therapy procedure within 1 weeks after AMI and PCI.

4. Hemodynamic stability—defined as no requirement for intra-aortic balloon pump or for inotropic or blood-pressure supporting medications.

5. Consent to protocol and agree to comply with all follow-up visits and studies.

Exclusion Criteria:

1. Presence of cardiogenic shock ( defined as systolic blood pressure < 80 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation);

2. Major bleeding requiring blood transfusion after acute reperfusion treatment;

3. A history of leucopenia;

4. Thrombocytopenia;

5. Hepatic or renal dysfunction;

6. Evidence for malignant diseases;

7. Unwillingness to participate;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-Elevation Myocardial Infarction

Intervention

Genetic:
• intracoronary human umbilical WJ-MSC transfer
intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.

Locations

Country	Name	City	State
China	Fu Cheng Lu 6	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing	Chinese PLA General Hospital, First People's Hospital of Foshan, General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

References & Publications (1)

1.Monya Baker. How to fix a broken heart? Nature. 2009; 460:18-19. 2.Psaltis PJ, Zannettino A, Worthley SG. Mesenchymal stromal cells potential for cardiovascular repair. Stem cells.2008; 10:1634. 3.Deryl L, Mark LT, Weiss, et al. Concise review : wharton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify myocardium metabolic and perfusion measured by F-18-fluorodeoxyglucose (F-18-FDG) postremission tomography (PET) and 99 mTctetrofosmine single-photon (SPET), as well as global left ventricular ejection fraction measured by echocardiography.	The primary endpoints were differences between the two treatments and from baseline to 4 months in quantitative myocardial metabolic and perfusion images, as measured by 18F-FDG positron emission tomography and 99 mTctetrofosmine single-photon imaging. Left ventricular ejection fraction is measured by 16-segment 2-D echocardiography.	4 months- 1 year	Yes
Secondary	Secondary endpoints: safety will be determined by the assessment of major adverse coronary events (MACE).	Safety will be determined by the assessment of major adverse coronary events (MACE) defined as cardiac death, peri-procedural myocardial infarction, or any repeat coronary intervention at 4 months-1year. Furthermore, safety is also determined by the occurrence of stent thrombosis, arrhythmias events. immune system disorders. The trial will be monitored by a Data and Safety Monitoring Board (DSMB) and the trial will be discontinued in case of safety concerns.	4 months-1year	Yes