Status:
UNKNOWN
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)
Lead Sponsor:
Shandong University
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 An...
Detailed Description
Ankylosing spondylitis (AS) is a chronic, progressive inflammatory rheumatic disease involving primarily the sacroiliac joints and the axial skeleton. The main clinical features are back pain and prog...
Eligibility Criteria
Inclusion
- Patient age 18\~60 years old with plan to infuse MSCs.
- Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria
- Stable doses of sulfasalazine,methotrexate,thalidomide,hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted
- Patients must have an ECOG 0\~2.
- No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 umol/L.
- No severe infection.
- Each patient must sign written informed consent.
Exclusion
- Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)
- Psychiatric condition that would limit informed consent.
- HIV, hepatitis B or C, tuberculosis, other infections
- Positive Pregnancy Test or lactation
- Patient has enrolled another clinical trial study within last 4 weeks.
- Contraindications to MSC
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01420432
Start Date
January 1 2011
End Date
December 1 2013
Last Update
August 19 2011
Active Locations (1)
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1
Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, China, 250033