Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI)
WJ-MSC-AMI
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)
1 other identifier
interventional
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 13, 2015
February 1, 2015
1 year
February 4, 2011
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Secondary endpoints: safety will be determined by the assessment of major adverse coronary events (MACE).
4 months-1year
Study Arms (1)
WJ-MSC
EXPERIMENTALWharton's jelly- Derived Mesenchymal Stem Cells Transfer
Interventions
intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.
Eligibility Criteria
You may qualify if:
- Patients at least 18 years of age；
- 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.
- No contraindications to undergoing cell-therapy procedure within 1 weeks after AMI and PCI.
- Hemodynamic stability-defined as no requirement for intra-aortic balloon pump or for inotropic or blood-pressure supporting medications.
- Consent to protocol and agree to comply with all follow-up visits and studies.
You may not qualify if:
- Presence of cardiogenic shock ( defined as systolic blood pressure \< 80 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation);
- Major bleeding requiring blood transfusion after acute reperfusion treatment;
- A history of leucopenia;
- Thrombocytopenia;
- Hepatic or renal dysfunction;
- Evidence for malignant diseases;
- Unwillingness to participate;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Navy General Hospital, Beijinglead
- Chinese PLA General Hospitalcollaborator
- General Hospital of Chinese Armed Police Forcescollaborator
- First People's Hospital of Foshancollaborator
Study Sites (1)
Fu Cheng Lu 6
Beijing, 100048, China
Related Publications (2)
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's jelly-derived cells are a primitive stromal cell population. Stem Cells. 2008 ; 26 :591-599. 4.Nekanti U, Rao VB, Bahirvani AG, Ta M, et al. Long-term Expansion and Pluripotent Marker Array Analysis of Wharton's Jelly-Derived Mesenchymal Stem Cells. Stem Cells and Dev. 2010; 19:117-130. 5.Chen MY, Lie PC, Li ZL. Endothelial differentiation of Wharton's jelly-derived mesenchymal stem cells in comparison with bone marrow-derived mesenchymal stem cells. Exp Hematol. 2009;37(5):629-40.. 6.Wu KH, Mo XM, Zhou, B. et al. Cardiac potential of stem cells from whole human umbilical cord tissue. Journal of Cellular Biochemistry. 2009; 107:926-932.
RESULTGao LR, Chen Y, Zhang NK, Yang XL, Liu HL, Wang ZG, Yan XY, Wang Y, Zhu ZM, Li TC, Wang LH, Chen HY, Chen YD, Huang CL, Qu P, Yao C, Wang B, Chen GH, Wang ZM, Xu ZY, Bai J, Lu D, Shen YH, Guo F, Liu MY, Yang Y, Ding YC, Yang Y, Tian HT, Ding QA, Li LN, Yang XC, Hu X. Intracoronary infusion of Wharton's jelly-derived mesenchymal stem cells in acute myocardial infarction: double-blind, randomized controlled trial. BMC Med. 2015 Jul 10;13:162. doi: 10.1186/s12916-015-0399-z.
PMID: 26162993DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lian Ru Gao, MD
Cardiology Division of Navy General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 8, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
July 1, 2012
Last Updated
February 13, 2015
Record last verified: 2015-02