NCT02809781

Brief Summary

The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to treat this disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

June 16, 2016

Last Update Submit

June 22, 2016

Conditions

SpondylitisSpondylitis, AnkylosingAnkylosisArthritisSpondylarthritisSpondylarthropathiesSpinal DiseasesMusculoskeletal DiseasesBone Diseases

Keywords

ankylosing spondylitismesenchymal stem celletanercept

Outcome Measures

Primary Outcomes (1)

  • The Assessment of Spondyloarthritis International Society (ASAS)20 response

    ASAS measures symptomatic improvement in AS patients.ASAS=4 domains:patient global assessment of disease activity,pain,function,inflammation.ASAS 20=20% improvement(vs.baseline)and an absolute change≥1 units on a 0-10 scale(0=no disease activity;10=high disease activity)for ≥3 domains,and no worsening in remaining domain.

    48 weeks

Secondary Outcomes (8)

  • BASDAI score comparing to baseline

    48 weeks

  • BASFI score comparing to baseline

    48 weeks

  • Imageology

    48 weeks

  • C-reactive protein (CRP)

    12 weeks

  • Erythrocyte sedimentation rate (ESR)

    12 weeks

  • +3 more secondary outcomes

Other Outcomes (2)

  • Percentage of systemic T cell population

    12 weeks

  • Side effects

    48 weeks

Study Arms (2)

Intravenous infusion of MSCs

EXPERIMENTAL

Human bone marrow-derived MSCs at a dose of 1.0E+6 MSC/kg, receive infusion per week in the first 4 weeks and every two weeks in the second 8 weeks. total for 12 weeks.

Biological: Intravenous infusion of MSCs

Etanercept

ACTIVE COMPARATOR

50mg,hypodermic injection,once per week, for 12 weeks

Drug: Etanercept

Interventions

Intravenous infusion of MSCsBIOLOGICAL

Intravenous infusion of MSCs:Human bone marrow-derived MSCs 1.0E+6 MSC/kg, IV drop

Intravenous infusion of MSCs
EtanerceptDRUG

50mg,hypodermic injection,once per week, for 12 weeks

Also known as: TNF alpha receptor inhibitor
Etanercept

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The male or female patient aged 18 to 45 years;
  • Fulfill 1984 modified NewYork classification criteria for AS;
  • The score of the Bath AS Disease Activity Index (BASDAI)≥40 on (0-100) despite optimal non-steroidal anti-inflammatory drug (NSAID) treatment.
  • Before each experiment, patients subscribe voluntarily to the agreement approved by Ethics Committees and sign the date.

You may not qualify if:

  • The patient diagnosed in doubt;
  • Completely stiff spine
  • Received spinal or joint surgery within 2 months
  • Received anti-TNF therapy within 3 months
  • pregnant or suckling period female patients;
  • Patients with the Medical or mentally imbalance charged by researchers. patients associated cardiovascular, cerebrovascular, liver,renal and hematological system diseases or mental disease;
  • Patients could not accept the research or could not cooperate well. Patients with other sever diseases at the same time, such as abnormality of joints, other seronegative spondyloarthropathy, or other Rheumatic Diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

SpondylitisSpondylitis, AnkylosingAnkylosisArthritisSpondylarthritisSpondylarthropathiesSpinal DiseasesMusculoskeletal DiseasesBone Diseases

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsAxial SpondyloarthritisJoint Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Shen Huiyong, Doctor

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Huiyong, Doctor

CONTACT

+8602081332612shenhuiyong@aliyun.com

Wang Peng, Doctor

CONTACT

+8602081332612770858492@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Orthopedics, Sun Yat-sen Memorial Hospital

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

CN(1)