Complications of Organ Transplant Stem Cells Umbilical Cord
Conditions
Keywords
Mesenchymal Stem Cells (MSC), Umbilical Cord, thymocyte globulin (ATG), Severe Aplastic Anemia (SAA)
Brief summary
Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and takes part in the bone marrow microenvironment. The response rate of early treatment on Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG treatment) is associated with long-term effect. The injection of Umbilical Cord Derived Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.
Detailed description
1. Mesenchymal Stem Cells were prepared by in vitro separation, screening, and culture from healthy human umbilical cord tissue; The injection of mesenchymal stem cells (umbilical) manufacturing and verification regulation was also formulated. 2. The starting dose of Umbilical Cord Derived MSC was 0.5-1.0 \* 106 cells /kg, based on the previous human studies; And the maximum tolerated dose was 1 \* 107 cells /kg 3. The response and complete remission rate, relapse rate of the injection of Umbilical Cord Derived Mesenchymal Stem Cells (or combined with ATG ) for Child with SAA were determined.
Interventions
DRUGMSC+ATG
MSC+ATG:Starting dose was 0.5-1.0 × 106 cells /kg; And the maximum tolerated dose was 1 ×107 cells /kg after ATG application.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-Severe Aplastic Anemia (NSAA)atients
Exclusion criteria
* Severe Aplastic Anemia (SAA) patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The response and complete remission rate with different doses of Umbilical Cord Derived MSC to treat child with SAA | 1 year | Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count \>100\*109/L, and absolute neutrophil count (ANC) \>1.5\*1.0 9/L. Partial response (PR) was defined as injection independence, reticulocyte count\>30\*109/L, platelet count \>20\*109/L, and ANC\>0.5\*1.0 9/L above the baseline. Persistence of injection requirement or death was evidence of no response (NR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The relapse rate with different doses of MSC to treat child with SAA | 3-10 year | The relapse was defined as injection dependence again; or progressed or paroxysmal nocturnal hemoglobinuria (PNH)/acute myeloid leukemia/myelodysplasia syndrome(MDS); or cyclosporin A (CsA) dependence. |
Countries
China
Contacts
Primary ContactXiaofan Zhu, MD
Outcome results
None listed