Status:
UNKNOWN
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic Anemia
Lead Sponsor:
Shandong University
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Aplastic Anemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 se...
Detailed Description
Severe aplastic anemia (SAA) is a condition that involves a low level of red blood cells, white blood cells, and platelets without evidence of another bone marrow disease. Patients with severe aplasti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Psychiatric condition that would limit informed consent.
- HIV positive
- Positive Pregnancy Test
- Patient has enrolled another clinical trial study within last 4 weeks.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01182662
Start Date
August 1 2010
End Date
August 1 2013
Last Update
August 31 2010
Active Locations (1)
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1
Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, China, 250033