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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01709656

Enrollment

120

Registered

2012-10-18

Start date

2012-03-31

Completion date

2014-12-31

Last updated

2015-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Brief summary

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

Interventions

BIOLOGICALMSC

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.

DRUGcelecoxib, 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame
the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria	24 weeks

Secondary

Measure	Time frame
BASDAI score comparing to baseline	24 weeks
BASFI score comparing to baseline	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026