Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease (TPAABPIHD)

July 20, 2015 updated by: Xuetao Pei, Academy Military Medical Science, China
The purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age under 75;
  • Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
  • NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
  • No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
  • No psychiatric illnesses and speaking dysfunction;
  • Informed consent.

Exclusion Criteria:

  • More than 75 years old;
  • LVEF<24%;
  • Unstable hemodynamics, shock;
  • Severe infection;
  • Patients have tumor or other lethal diseases (expectation of life<6 months);
  • Radiation patients;
  • hematopoietic malignancy including Haemophiliacs;
  • Anemia (Hb<100g/L);
  • The other clinical trial participants within one month;
  • Abnormal increasing of the blood biochemical indicators that is not explained by the conditions;
  • Informed refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pre-conditioned BMMSCs
autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
Biological: BMMSCs
Active Comparator: BMMSCs
autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
Biological: BMMSCs
Sham Comparator: Controls
standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.
Biological: BMMSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LVEF (left ventricular ejection fraction)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academy Military Medical Science, China

Collaborators

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMMSC-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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