Aplastic Anemia
Conditions
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 .
Interventions
BIOLOGICALmesenchymal 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.
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJun Zhang, Master
Outcome results
None listed