NCT00953485

Brief Summary

This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of primary Sjögren's Syndrome (pSS) who have been resistant to multiple standard treatments. The underlying hypothesis is that the pSS condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

1.5 years

First QC Date

August 4, 2009

Last Update Submit

August 19, 2009

Conditions

Sjogren's SyndromeMesenchymal Stem Cells

Keywords

Sjogren's SyndromeMesenchymal Stem CellsTransplantation

Outcome Measures

Primary Outcomes (1)

  • Sjögren's syndrome disease activity index

    Monthly

Secondary Outcomes (2)

  • pSS Serology (ANA, dsDNA, SS-A, SS-B)

    Monthly

  • Improvement of salivary gland function (measured as stimulated saliva flow rate)

    Monthly

Interventions

Allogeneic Mesenchymal Stem Cells (AlloMSC)BIOLOGICAL

Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10\^6 cells/kg body weight).

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients fulfilled the international classification criteria (2002) for primary Sjögren's Syndrome, man or woman aged from 15 to 70 years old, Sjögren's Syndrome Disease Activity Index (SSDAI)≥8.
  • Stimulated whole saliva flow rate less than 1\~6ml/6min.
  • Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
  • Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial and for 12 months following treatment. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.

You may not qualify if:

  • End-stage renal failure.
  • Severe cardiopulmonary compromise, or other system failure.
  • Active, uncontrolled infections.
  • Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (5)

  • Sun L, Akiyama K, Zhang H, Yamaza T, Hou Y, Zhao S, Xu T, Le A, Shi S. Mesenchymal stem cell transplantation reverses multiorgan dysfunction in systemic lupus erythematosus mice and humans. Stem Cells. 2009 Jun;27(6):1421-32. doi: 10.1002/stem.68.

    PMID: 19489103BACKGROUND

  • Liang J, Zhang H, Hua B, Wang H, Wang J, Han Z, Sun L. Allogeneic mesenchymal stem cells transplantation in treatment of multiple sclerosis. Mult Scler. 2009 May;15(5):644-6. doi: 10.1177/1352458509104590.

    PMID: 19389752BACKGROUND

  • Zhou K, Zhang H, Jin O, Feng X, Yao G, Hou Y, Sun L. Transplantation of human bone marrow mesenchymal stem cell ameliorates the autoimmune pathogenesis in MRL/lpr mice. Cell Mol Immunol. 2008 Dec;5(6):417-24. doi: 10.1038/cmi.2008.52.

    PMID: 19118507BACKGROUND

  • Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8. doi: 10.1177/0961203306075793.

    PMID: 17402368BACKGROUND

  • Xu J, Wang D, Liu D, Fan Z, Zhang H, Liu O, Ding G, Gao R, Zhang C, Ding Y, Bromberg JS, Chen W, Sun L, Wang S. Allogeneic mesenchymal stem cell treatment alleviates experimental and clinical Sjogren syndrome. Blood. 2012 Oct 11;120(15):3142-51. doi: 10.1182/blood-2011-11-391144. Epub 2012 Aug 27.

    PMID: 22927248DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Lingyun Sun, MD

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingyun Sun, MD

CONTACT

+86-25-83105219lingyunsun2001@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations

CN(1)