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

Academy Military Medical Science, China

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Myocardial Infarction; Acute Myocardial Infarction; Ischemic Cardiomyopathy

Treatments: Biological: BMMSCs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02504437

BMMSC-1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups

pre-conditioned BMMSCs

Experimental group

Description:

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

Treatment:

Biological: BMMSCs

BMMSCs

Active Comparator group

Description:

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

Treatment:

Biological: BMMSCs

Controls

Sham Comparator group

Description:

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

Treatment:

Biological: BMMSCs