Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic Anemia
NCT ID: NCT01182662
Last Updated: 2010-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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Detailed Description
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Although immune-suppressing drugs, such as corticosteroids, CsA and ATG, have been used in the treatment of SAA, however, many studies have indicated that the overall response rate to these drugs is less than 60%. Addition, the severe side effects of these immune-suppressing drugs have also been observed. The management of SAA patients therefore remains unsatisfactory and targeted therapies are needed. Human MSCs isolated from human 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 transplantation in the SAA patients.
This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant and CsA therapy (experimental group) or CsA therapy alone (control group). Patients will undergo MSC transplant at the start of the study on Day 0. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.
Conditions
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Keywords
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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 and cyclosporin
Human umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated to apply in trimonthly for 2 cycle and CsA 5mg/kg po for 12 months
Human umbilical cord-derived MSCs and cyclosporin A
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle and cyclosporin A 5mg/kg po for 12 months
cyclosporine A
cyclosporine A at a dose of 5 mg CsA/kg
cyclosporin A
cyclosporin A 5mg/kg po for 12 months
Interventions
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Human umbilical cord-derived MSCs and cyclosporin A
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle and cyclosporin A 5mg/kg po for 12 months
cyclosporin A
cyclosporin A 5mg/kg po for 12 months
Eligibility Criteria
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Inclusion Criteria
2. Standard of diagnosis of aplastic anemia is according to Chinese domestic classification of AA for 1987.
3. Patients must have an ECOG 0\~2.
4. No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 umol/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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chengyun zheng, Ph. D
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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chengyun zheng, Ph. D
Role: primary
Other Identifiers
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No. 30670903
Identifier Type: OTHER
Identifier Source: secondary_id
kongdx
Identifier Type: -
Identifier Source: org_study_id