Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

Sponsor

Hebei Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03055078

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aplastic Anemia	Biological: mesenchymal stem cells	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: mesenchymal stem cells 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.

Arm

Intervention/Treatment

Experimental: 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.

Biological: mesenchymal stem cells

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
adverse reaction [Post cell transplantation: 1, 3, 6, 9months]
Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of AA according to established criteria in 2010
Age from 14 to 60 years
Suffering from AA within six months
No serious infection or acute hemorrhage.
Left ventricular ejection fraction (LVEF) ≥ 50%
No acute infectious diseases.
Understanding and willingness to sign a written informed consent document.
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.

Severe aplastic anemia(SAA) with severe infection.
Severe aplastic anemia(SAA) with active hemorrhage.
Severe heart attack, liver and kidney disease following serious complications
Patients with allergic constitution.
Pregnancy and lactation.
Accompanied by malignant tumors and other clonal disease.
Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050031

Sponsors and Collaborators

Hebei Medical University

Investigators

Study Chair: Baoyong Yan, Doctor, The First Hospital of Hebei Medical University
Study Director: Qingchi Liu, Doctor, The First Hospital of Hebei Medical University
Study Director: Quanhai Li, Doctor, The First Hospital of Hebei Medical University
Principal Investigator: Xiaohui Jia, Doctor, The First Hospital of Hebei Medical University
Principal Investigator: Xianyun Wang, Doctor, The First Hospital of Hebei Medical University
Principal Investigator: Fan Zhang, Bachelor, The First Hospital of Hebei Medical University
Principal Investigator: Yang Shen, Master, The First Hospital of Hebei Medical University
Principal Investigator: Bing Ma, Master, The First Hospital of Hebei Medical University
Principal Investigator: Wanyi Yin, Master, The First Hospital of Hebei Medical University
Principal Investigator: Dan Zhao, Master, The First Hospital of Hebei Medical University
Principal Investigator: Bojian Sun, Master, The First Hospital of Hebei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HeibeiMU, Hebei Medical University

ClinicalTrials.gov Identifier:

NCT03055078

Other Study ID Numbers:

17277787D-AA

First Posted:

Feb 16, 2017

Last Update Posted:

Apr 7, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Anemia

Anemia, Aplastic

Study Results

No Results Posted as of Apr 7, 2017