Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia
Primary Purpose
Aplastic Anemia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Aplastic Anemia
Eligibility Criteria
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.
Sites / Locations
- the First Hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mesenchymal stem cells
Arm Description
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.
Outcomes
Primary Outcome Measures
Hemoglobin levels in peripheral blood
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
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
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
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
The status of megakaryocytic series is evaluated by platelet count (×10^9/L) in peripheral blood.
adverse reaction
Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.
Full Information
NCT ID
NCT03055078
First Posted
February 4, 2017
Last Updated
April 6, 2017
Sponsor
Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03055078
Brief Title
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia
Official Title
Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aplastic Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin levels in peripheral blood
Description
The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.
Time Frame
Post cell transplantation: 9months
Secondary Outcome Measure Information:
Title
The number of red blood cell in peripheral blood
Description
The improvement of bone marrow erythrocyte is evaluated by red blood cell count (×10^12/L) in peripheral blood.
Time Frame
Post cell transplantation: 1, 3, 6, 9months
Title
The number of granulocyte in peripheral blood
Description
The recovery of bone marrow granulocyte is evaluated by granulocyte count (×10^9/L) in peripheral blood.
Time Frame
Post cell transplantation: 1, 3, 6, 9months
Title
The number of white blood cell in peripheral blood
Description
The improvement of bone marrow granulocyte is evaluated by white blood cell count (×10^9/L) in peripheral blood.
Time Frame
Post cell transplantation: 1, 3, 6, 9months
Title
The evaluation of bone marrow megakaryocytic series
Description
The status of megakaryocytic series is evaluated by platelet count (×10^9/L) in peripheral blood.
Time Frame
Post cell transplantation: 1, 3, 6, 9months
Title
adverse reaction
Description
Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.
Time Frame
Post cell transplantation: 1, 3, 6, 9months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhang, Master
Phone
86-311-85917384
Email
june_luck@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoyong Yan, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Qingchi Liu, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Quanhai Li, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiaohui Jia, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xianyun Wang, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fan Zhang, Bachelor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yang Shen, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bing Ma, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wanyi Yin, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Zhao, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bojian Sun, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, Master
Phone
86-311-85917384
Email
june_luck@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia
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