NCT02666391

Brief Summary

The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2016

Status
unknown

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

First Submitted

Initial submission to the registry

January 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

January 21, 2016

Last Update Submit

January 24, 2016

Conditions

Acute Myocardial InfarctionMyocardial InfarctionIschemic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

  • Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.

    1 week, 6 month, 12 month,18 month

  • Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).

    1 week, 18 month

Secondary Outcomes (3)

  • Pump failure Killip classification

    baseline, 1 week, 1 month, 6 month, 12 month,18 month

  • New York Heart Association(NYHA) classification

    1 week, 1 month, 6 month, 12 month,18 month

  • Occurrence of major adverse event

    3 day, 1 week, 1 month, 6 month, 12 month,18 month

Study Arms (2)

UCMSCs

EXPERIMENTAL

Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)

Biological: umbilical cord mesenchymal stem cells

controls

NO INTERVENTION

Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion

Interventions

umbilical cord mesenchymal stem cellsBIOLOGICAL
UCMSCs

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
  • LVEF (left ventricular ejection fraction): 25-45%;
  • Age between 18 and 70, borh gender;
  • Women of childbearing age agreed to take contraceptive measures during the whole study period;
  • No psychiatric illnesses and speaking dysfunction;
  • Informed consent.

You may not qualify if:

  • Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF\<24%;
  • Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
  • Patients suffered from severe arrhythmia;
  • Patients suffered from stent thrombosis;
  • Patients receiving immunosuppressive therapy;
  • Patients have tumor or other lethal diseases (expectation of life\<6 months);
  • Women who plan to be pregnant or are pregnant or nursing;
  • Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
  • Other clinical trial participants within 3 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.

    PMID: 23651816BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Xuetao Pei, M.D., Ph.D

CONTACT

8610-68164807AMMS0906@163.com

Junnian Zhou, Ph.D

CONTACT

8620-89199011zhoujunnian@scrm.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 28, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 28, 2016

Record last verified: 2016-01