Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

Hebei Medical University10 enrolled

Overview

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.

Aplastic anemia (AA) is a disorder thought to be caused by an immune-mediated bone marrow failure. Not all people with AA are eligible for today's standard treatments. One new treatment approach uses umbilical cord derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to provide the basis for clinical application. The aim of the present study is to investigate the safety and efficacy of vein infusion of allogeneic mesenchymal stem cells in patients with AA .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aplastic Anemia

Interventions

mesenchymal stem cellsBIOLOGICAL

Patients in the cell treated group were given umbilical cord derived mesenchymal stem cells by intravenous infusion besides conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1months, 3months, 6months and 9months were evaluated respectively the therapeutic effect.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of AA according to established criteria in 2010 2. Age from 14 to 60 years 3. Suffering from AA within six months 4. No serious infection or acute hemorrhage. 5. Left ventricular ejection fraction (LVEF) ≥ 50% 6. No acute infectious diseases. 7. Understanding and willingness to sign a written informed consent document. 8. Eastern Cooperative Oncology Group(ECOG) score of 0-2pionts. Exclusion Criteria: \- Patients with AA have to be disqualified from this study if any of the following is applicable. 1. Severe aplastic anemia(SAA) with severe infection. 2. Severe aplastic anemia(SAA) with active hemorrhage. 3. Severe heart attack, liver and kidney disease following serious complications 4. Patients with allergic constitution. 5. Pregnancy and lactation. 6. Accompanied by malignant tumors and other clonal disease. 7. Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.

Locations (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Outcomes

Primary Outcomes

Hemoglobin levels in peripheral blood

The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.

Time frame: Post cell transplantation: 9months

Secondary Outcomes

The number of red blood cell in peripheral blood

The improvement of bone marrow erythrocyte is evaluated by red blood cell count (×10\^12/L) in peripheral blood.