Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease

Phase 1

• Conditions: Myocardial Infarction; Acute Myocardial Infarction; Ischemic Cardiomyopathy
• Interventions: Biological: BMMSCs

• Registration Number: NCT02504437
• Lead Sponsor: Academy Military Medical Science, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-20
• Last Update Submitted: 2015-07-20
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22
• Study Start: 2015-11
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-conditioned BMMSCs	BMMSCs	autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
BMMSCs	BMMSCs	autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
Controls	BMMSCs	standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.

Primary Outcome Measures

Name	Time	Method
LVEF (left ventricular ejection fraction)	one year