Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic Syndromes
NCT ID: NCT01129739
Last Updated: 2010-05-25
Study Results
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Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2010-05-31
2013-05-31
Brief Summary
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Detailed Description
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To date treatment of MDS is unsatisfactory: chemotherapy has a limited role in the management of leukemic progression; autologous stem cell transplantation does not prolong relapse-free survival and stem cell transplantation is poorly tolerated in older individuals. Some MDS patients have been shown to respond to a wide variety of immunosuppressive agents ranging from corticosteroids to CsA and antithymocyte globulin (ATG). However, the overall response rate is less than 30%. In fact, few treatments appear to change the natural history of MDS.
The management of MDS patients therefore remains to be improved. Human MSCs isolated from Wharton's jelly of the umbilical cord/placenta have been shown to have immunosuppressive, stimulating hematopoiesis and tissue repairing properties. This study will evaluate the safety and effectiveness of MSC transplant in the MDS patients.
This study will last about 3 years. Participants will be randomly assigned to receive either MSC transplant (Group 1) or CsA therapy alone (Group 2). Patients will undergo MSC transplant at the start of the study (defined as Day 0). After 3 months, patients will receive the second MSC transplantation when one responds well to the treatment. After 3, 6 and 12 months from the first transplantation, patients will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Human umbilical cord-derived MSCs
Human umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated to apply in trimonthly for 2 cycle
Human umbilical cord-derived MSCs
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
cyclosporine A (CsA)
CsA at a dose of 5 mg CsA/kg
cyclosporine A (CsA)
CsA 5mg/kg po for 6 months
Interventions
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Human umbilical cord-derived MSCs
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
cyclosporine A (CsA)
CsA 5mg/kg po for 6 months
Eligibility Criteria
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Inclusion Criteria
2. Histologically documented or cytologically confirmed diagnosis of MDS with WHO classification of MDS-RA and MDS-RARS.
3. Patients must have an ECOG 0\~2.
4. No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 mmol/L.
5. No active severe viral or fungus infection.
6. Each patient must sign written informed consent.
Exclusion Criteria
2. HIV positive
3. Positive Pregnancy Test
4. Patient has enrolled another clinical trial study within last 4 weeks.
18 Years
80 Years
ALL
No
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
Shandong University
OTHER
Responsible Party
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Department of Hematology of the 2nd Hospital of Shandong University
Principal Investigators
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cheng yun zheng, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology of The 2nd Hospital of Shandong University
Locations
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Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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No. 30670903
Identifier Type: OTHER
Identifier Source: secondary_id
CZheng
Identifier Type: -
Identifier Source: org_study_id
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