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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01709656
First Posted: October 18, 2012
Last Update Posted: February 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Gu Jieruo, 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 ]

Secondary Outcome Measures:
  • BASDAI score comparing to baseline [ Time Frame: 24 weeks ]
  • BASFI score comparing to baseline [ Time Frame: 24 weeks ]

Enrollment: 120
Study Start Date: March 2012
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709656


Locations
China, Guangdong
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
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

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
First Submitted: October 10, 2012
First Posted: October 18, 2012
Last Update Posted: February 11, 2015
Last Verified: February 2015

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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents