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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01709656
First received: October 10, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Ankylosing Spondylitis
Biological: MSC
Drug: "celecoxib", "Celebrex®"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BASDAI score comparing to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • BASFI score comparing to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSC plus NSAID

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

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
Experimental: NSAID
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®"
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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709656

Contacts
Contact: Jieruo Gu, M.D. +8620-85252055 gujieruo@163.com

Locations
China, Guangdong
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Jieruo Gu, M.D.    +8620-85252055    gujieruo@163.com   
Principal Investigator: Jieruo Gu, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Jieruo Gu, M.D. Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Gu Jieruo, Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01709656     History of Changes
Other Study ID Numbers: [2012]2-31
Study First Received: October 10, 2012
Last Updated: May 19, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Celecoxib
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014