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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709656
• Other study ID #: [2012]2-31
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: February 10, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• MSC
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.

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

Locations

Country	Name	City	State
China	Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria		24 weeks	No
Secondary	BASDAI score comparing to baseline		24 weeks	No
Secondary	BASFI score comparing to baseline		24 weeks	No