Ankylosing Spondylitis | A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
Ankylosing Spondylitis research study
What is the primary objective of this study?
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
Who is eligible to participate?
Inclusion Criteria: 1. Aged from 16-65 years, sign the Informed Consent 2. Fulfill 1984 modified NewYork classification criteria for AS 3. 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. 4. Commitment to contraceptive for woman Exclusion Criteria: 1. Completely stiff spine 2. Received spinal or joint surgery within 2 months 3. Received anti-TNF therapy within 3 months 4. History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis 5. Female of pregnancy or breast feeding 6. 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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:MSChuman 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.
Drug:"celecoxib", "Celebrex®"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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MSC plus NSAIDhuman 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.
NSAIDnon-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.
Start Date: March 2012
Completed Date: December 2014
Primary Outcome: the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria
Secondary Outcome: BASDAI score comparing to baseline
Study sponsors, principal investigator, and references
Principal Investigator: Jieruo Gu, M.D.
Lead Sponsor: Sun Yat-sen University