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

Sun Yat-sen University

Status: Completed

Conditions: Ankylosing Spondylitis

Treatments: Drug: "celecoxib", "Celebrex®"; Biological: MSC

Study type: Interventional

Funder types: Other

Identifiers

NCT01709656

[2012]2-31

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 2 patient groups

MSC plus NSAID

Experimental group

Description:

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.

Treatment:

Drug: "celecoxib", "Celebrex®"

Biological: MSC

NSAID

Experimental group

Description:

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.

Treatment:

Drug: "celecoxib", "Celebrex®"