Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease

NCT ID: NCT02504437

Last Updated: 2015-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Acute Myocardial Infarction Ischemic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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pre-conditioned BMMSCs

autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.

Group Type EXPERIMENTAL

BMMSCs

Intervention Type BIOLOGICAL

BMMSCs

autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.

Group Type ACTIVE_COMPARATOR

BMMSCs

Intervention Type BIOLOGICAL

Controls

standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.

Group Type SHAM_COMPARATOR

BMMSCs

Intervention Type BIOLOGICAL

Interventions

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BMMSCs

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Academy Military Medical Science, China

INDUSTRY

Sponsor Role lead

Responsible Party

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Xuetao Pei

Director, Head of South China Research Center for Stem Cell & Regenerative Medicine, AMMS, Guangzhou, China.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Xuetao Pei, M.D., Ph.D

Role: CONTACT

8610-68164807

Junnian Zhou, Ph.D

Role: CONTACT

8620-89199011

References

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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.

Reference Type BACKGROUND
PMID: 23651816 (View on PubMed)

Other Identifiers

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BMMSC-1

Identifier Type: -

Identifier Source: org_study_id

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