A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis

Study Overview
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Brief Summary
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The investigators will recruit active ankylosing spondylitis patients for injection treatment of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs) and sera before and after the treatment of 24 weeks to test the gene expression profiles and study related pathogenesis of AS

Official Title
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A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Biological: MSC
* Drug: celecoxib, Celebrex®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 16-65 years, sign the Informed Consent Fulfill 1984 modified NewYork classification criteria for AS Have an active refractory disease defined by a score ≥40 on the Bath AS Disease Activity Index (BASDAI) (0-100) despite optimal non-steroidal anti-inflammatory drug (NSAID) treatment. Commitment to contraceptive for woman Exclusion Criteria: Completely stiff spine Received spinal or joint surgery within 2 months Received anti-TNF therapy within 3 months History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis Female of pregnancy or breast feeding Hb≤ 9g/dl for male or Hb ≤ 8.5 g/dl for male, ALT/AST≥2folds of upper level normal range, Creatine≥120mol/L(≤1.4mg/dl)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC plus NSAID<br>human mesenchymal stem cells:1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment, plus non-steroid anti-inflammatory drugs (NSAID: celecoxib, Celebrex® 0.2g Bid(twice a day),PO (Per Os). Duration of treatment:24 weeks for follow up. collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent. | Biological: MSC<br>* human mesenchymal stem cells,1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment. a total of 24 weeks for follow up.<br>Drug: celecoxib, Celebrex®<br>* non-steroid anti-inflammatory drugs (NSAID):celecoxib, Celebrex® 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up<br>|
| Experimental: NSAID<br>non-steroid anti-inflammatory drugs (NSAID: celecoxib, Celebrex® 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up;collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent. | Drug: celecoxib, Celebrex®<br>* non-steroid anti-inflammatory drugs (NSAID):celecoxib, Celebrex® 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BASDAI score comparing to baseline |  | 24 weeks | 
| BASFI score comparing to baseline |  | 24 weeks |