Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia
Evaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
1 other identifier
interventional
10
1 country
1
Brief Summary
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 4, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 7, 2017
April 1, 2017
1.9 years
February 4, 2017
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin levels in peripheral blood
The recovery of bone marrow erythrocyte is evaluated by hemoglobin levels (g/L) in peripheral blood.
Post cell transplantation: 9months
Secondary Outcomes (5)
The number of red blood cell in peripheral blood
Post cell transplantation: 1, 3, 6, 9months
The number of granulocyte in peripheral blood
Post cell transplantation: 1, 3, 6, 9months
The number of white blood cell in peripheral blood
Post cell transplantation: 1, 3, 6, 9months
The evaluation of bone marrow megakaryocytic series
Post cell transplantation: 1, 3, 6, 9months
adverse reaction
Post cell transplantation: 1, 3, 6, 9months
Study Arms (1)
mesenchymal stem cells
EXPERIMENTALAccording 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.
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Study Record Dates
First Submitted
February 4, 2017
First Posted
February 16, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
April 7, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share