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A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis

NCT02809781 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-06-24

No results posted yet for this study

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.

Conditions

  • Spondylitis
  • Spondylitis, Ankylosing
  • Ankylosis
  • Arthritis
  • Spondylarthritis
  • Spondylarthropathies
  • Spinal Diseases
  • Musculoskeletal Diseases
  • Bone Diseases

Interventions

BIOLOGICAL

Intravenous infusion of MSCs

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

DRUG

Etanercept

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Shen Huiyong, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-08-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809781 on ClinicalTrials.gov