Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

S

South China Research Center for Stem Cell and Regenerative Medicine

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Myocardial Infarction
Acute Myocardial Infarction
Ischemic Cardiomyopathy

Treatments

Biological: umbilical cord mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02666391
UCMSC-2

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Investigators judge other conditions not suitable for inclusion.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

UCMSCs
Experimental group
Description:
Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)
Treatment:
Biological: umbilical cord mesenchymal stem cells
controls
No Intervention group
Description:
Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion

Trial contacts and locations

0

Loading...

Central trial contact

Junnian Zhou, Ph.D; Xuetao Pei, M.D., Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems