NCT01420432

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS)

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 19, 2011

Status Verified

April 1, 2011

Enrollment Period

2.9 years

First QC Date

August 11, 2011

Last Update Submit

August 18, 2011

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing SpondylitisUmbilical Cord/placenta-Derived MSCTransplantation

Outcome Measures

Primary Outcomes (4)

  • 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 abosolute 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. Patient global Pain Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI) Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6)

    1 year

  • erythrocyte sedimentation rate (ESR)

    erythrocyte sedimentation rate (ESR) level will be mainly observed after transplanting 3, 6,12-month.

    1 year

  • imageology

    imageology will be mainly observed after transplanting 3, 6,12-month.

    1 year

  • C-reactive protein (CRP)

    C-reactive protein (CRP) level will be mainly observed after transplanting 3, 6,12-month.

    1 year

Secondary Outcomes (2)

  • Percentage of systemic T regulatory cell population

    1 year

  • Side effects

    1 year

Study Arms (2)

Human umbilical cord-derived MSCs and DMARDs

EXPERIMENTAL

Human umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated after three months and DMARDs such as sulfasalazine,methotrexate,thalidomide po for 12 months

Biological: Human umbilical cord-derived MSCs

DMARDs

NO INTERVENTION

DMARDs such as sulfasalazine,methotrexate,thalidomide po for 12 months

Interventions

Human umbilical cord-derived MSCsBIOLOGICAL

1.0E+6 MSC/kg, IV drop and repeat repeated after three months

Human umbilical cord-derived MSCs and DMARDs

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient age 18\~60 years old with plan to infuse MSCs.
  • Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria
  • Stable doses of sulfasalazine,methotrexate,thalidomide,hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted
  • Patients must have an ECOG 0\~2.
  • No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 umol/L.
  • No severe infection.
  • Each patient must sign written informed consent.

You may not qualify if:

  • Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)
  • Psychiatric condition that would limit informed consent.
  • HIV, hepatitis B or C, tuberculosis, other infections
  • Positive Pregnancy Test or lactation
  • Patient has enrolled another clinical trial study within last 4 weeks.
  • Contraindications to MSC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology of the 2nd Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • chengyun zheng, Ph. D

    Department of Hematology of The 2nd Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

chengyun zheng, Ph. D

CONTACT

+86-531-85875635chengyun.zheng@ki.se

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 19, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 19, 2011

Record last verified: 2011-04

Locations

CN(1)