Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

Phase 1

• Conditions: Aplastic Anemia
• Interventions: Biological: mesenchymal stem cells

• Registration Number: NCT03055078
• Lead Sponsor: Hebei Medical University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	mesenchymal stem cells	According to the inclusion and exclusion criteria, selected patients were divided into a cell therapy group and a control group. Umbilical cord derived mesenchymal stem cells at a dose of 100-300 million by intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Hemoglobin levels in peripheral blood	Post cell transplantation: 9months	The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.

Secondary Outcome Measures

Name	Time	Method
The number of red blood cell in peripheral blood	Post cell transplantation: 1, 3, 6, 9months	The improvement of bone marrow erythrocyte is evaluated by red blood cell count (×10\^12/L) in peripheral blood.
adverse reaction	Post cell transplantation: 1, 3, 6, 9months	Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.
The number of granulocyte in peripheral blood	Post cell transplantation: 1, 3, 6, 9months	The recovery of bone marrow granulocyte is evaluated by granulocyte count (×10\^9/L) in peripheral blood.
The number of white blood cell in peripheral blood	Post cell transplantation: 1, 3, 6, 9months	The improvement of bone marrow granulocyte is evaluated by white blood cell count (×10\^9/L) in peripheral blood.
The evaluation of bone marrow megakaryocytic series	Post cell transplantation: 1, 3, 6, 9months	The status of megakaryocytic series is evaluated by platelet count (×10\^9/L) in peripheral blood.

Trial Locations

Locations (1)

the First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China