Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
TPAABPIHD
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2015
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 22, 2015
July 1, 2015
2.1 years
July 14, 2015
July 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
LVEF (left ventricular ejection fraction)
one year
Study Arms (3)
pre-conditioned BMMSCs
EXPERIMENTALautologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
BMMSCs
ACTIVE COMPARATORautologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
Controls
SHAM COMPARATORstandard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Academy Military Medical Science, Chinalead
- Sun Yat-sen Universitycollaborator
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
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of South China Research Center for Stem Cell & Regenerative Medicine, AMMS, Guangzhou, China.
Study Record Dates
First Submitted
July 14, 2015
First Posted
July 22, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 22, 2015
Record last verified: 2015-07