Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic Anemia
Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat SAA
2 other identifiers
interventional
30
1 country
1
Brief 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 in subject for the therapy of severe aplastic anemia (SAA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 11, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 31, 2010
August 1, 2010
3 years
August 11, 2010
August 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
SAA clinical symptoms
Anemia symptoms, bleeding and infection will be mainly observed in every monthly after transplanting MSCs for one year.
1 year
The number of blood cells
The number of blood cells, which contains WBC, Neu, RBC, Hb,PLT and reticulocyte, will be mainly tested monthly after transplantion of MSCs for one year
1 year
Bone borrow hemocytology
Bone borrow cytomorphologic examination will be tested in every 3 months after transplantion of MSCs for one year.
1 year
Secondary Outcomes (1)
Percentage of systemic T regulatory cell population and T lymphocyte subsets
1 year
Study Arms (2)
Human umbilical cord-derived MSCs and cyclosporin
EXPERIMENTALHuman 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
cyclosporine A
ACTIVE COMPARATORcyclosporine A at a dose of 5 mg CsA/kg
Interventions
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
Eligibility Criteria
You may qualify if:
- Patient age 18\~80 years old with plan to infuse MSCs.
- Standard of diagnosis of aplastic anemia is according to Chinese domestic classification of AA for 1987.
- Patients must have an ECOG 0\~2.
- No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 umol/L.
- No active severe viral or fungus infection.
- Each patient must sign written informed consent.
You may not qualify if:
- Psychiatric condition that would limit informed consent.
- HIV positive
- Positive Pregnancy Test
- Patient has enrolled another clinical trial study within last 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- National Natural Science Foundation of Chinacollaborator
Study Sites (1)
Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, 250033, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
chengyun zheng, Ph. D
Department of Hematology of The 2nd Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 11, 2010
First Posted
August 17, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
August 31, 2010
Record last verified: 2010-08