NCT01709656

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

October 10, 2012

Last Update Submit

February 10, 2015

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria

    24 weeks

Secondary Outcomes (2)

  • BASDAI score comparing to baseline

    24 weeks

  • BASFI score comparing to baseline

    24 weeks

Study Arms (2)

MSC plus NSAID

EXPERIMENTAL

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: MSCDrug: "celecoxib", "Celebrex®"

NSAID

EXPERIMENTAL

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®"

Interventions

MSCBIOLOGICAL

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.

MSC plus NSAID
"celecoxib", "Celebrex®"DRUG

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

MSC plus NSAIDNSAID

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged from 16-65 years, sign the Informed Consent
  • Fulfill 1984 modified NewYork classification criteria for AS
  • 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.
  • Commitment to contraceptive for woman

You may not qualify if:

  • Completely stiff spine
  • Received spinal or joint surgery within 2 months
  • Received anti-TNF therapy within 3 months
  • History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
  • Female of pregnancy or breast feeding
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jieruo Gu, M.D.

    Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 18, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

CN(1)