Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic Syndromes
NCT01129739 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2010-05-25
Summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg on the subjects for refractory anemia (RA) and refractory anemia with ring sideroblast (RARS) of myelodysplastic syndromes (MDS).
Conditions
Interventions
- OTHER
-
Human umbilical cord-derived MSCs
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
- OTHER
-
cyclosporine A (CsA)
CsA 5mg/kg po for 6 months
Sponsors & Collaborators
-
National Natural Science Foundation of China
collaborator OTHER_GOV -
Shandong University
lead OTHER
Principal Investigators
-
cheng yun zheng, PhD · Department of Hematology of The 2nd Hospital of Shandong University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- China
Study Locations
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