NCT01946048

Brief Summary

The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

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

September 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

Same day

First QC Date

September 12, 2013

Last Update Submit

October 5, 2013

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • The examination of heart function

    Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.

    Post cell transplantation: 1, 3, 6 months

Secondary Outcomes (3)

  • all-cause mortality

    Post cell transplantation: one year

  • all-cause morbidity

    Post cell transplantation: one year

  • major adverse cardiac and cerebrovascular events

    Post cell transplantation: one year

Study Arms (1)

mesenchymal stem cells

EXPERIMENTAL

Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.

Biological: mesenchymal stem cells

Interventions

mesenchymal stem cellsBIOLOGICAL

Procedure: Selected patients were randomly divided into a cell therapy group and a control group. Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.

mesenchymal stem cells

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 30 to 80 years
  • ischemic cardiomyopathy
  • Left ventricular infarction area seriously low movement to no movement
  • The low whole left ventricular systolic function (LVEF 45% or less)
  • Have line or quasi coronary interventional treatment
  • Willing to accept patients with follow-up evaluation
  • Have signed informed consent form approved by the ethics committee

You may not qualify if:

  • Non elevation between S-wave and T-wave in patients with acute myocardial infarction
  • No function damage in patients with acute myocardial infarction
  • Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
  • Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
  • Acute infectious diseases
  • Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
  • Severe renal disease, creatinine clearance \< 36 ml/min, serum creatinine \> 265 umol/L
  • Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) \> 4 times the upper limit of normal
  • Unstable cerebral lesions
  • malignant tumor
  • Cognitive dysfunction and dementia patients, patients with severe mental illness
  • Patients with severe physical disabilities can't regular follow-up
  • Other serious uncontrolled system disease
  • To prepare or have the pregnancy women patients
  • Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Study Officials

  • Baoyong Yan, Doctor

    The First Hospital of Hebei Medical University

    STUDY CHAIR

  • Gang Liu, Doctor

    The First Hospital of Hebei Medical University

    STUDY DIRECTOR

  • Guoping Ma, Master

    The First Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

  • Jun Zhang, Master

    The First Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 19, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2014

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

CN(1)