Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)

Last updated: August 19, 2009
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Trial Status Unknown

Phase

1/2

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT00953485
NJGLYY002
  • Ages 15-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients fulfilled the international classification criteria (2002) for primarySjögren's Syndrome, man or woman aged from 15 to 70 years old, Sjögren's SyndromeDisease 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 writteninformed consent in accordance with the institutional and hospital guidelines.

  • Women of reproductive potential may not participate unless they have agreed to use aneffective contraceptive method while on this trial and for 12 months followingtreatment. Women of child-bearing potential must have a pregnancy test performedwithin 72 hours prior to initiation of treatment.

Exclusion

Exclusion Criteria:

  • 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 orharm to nursing infants from this treatment regimen.

Study Design

Total Participants: 20
Study Start date:
June 01, 2009
Estimated Completion Date:
December 31, 2011

Study Description

  • To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory primary Sjögren's Syndrome (pSS)

  • To determine the disease-free survival in pSS patients treated with MSCT in terms of disease activity index, pSS serology and salivary gland function

  • To assess adverse events of allogeneic MSC transplantation

  • To assess the association of disease activity index, pSS serology levels, and saliva flow rate at baseline with disease-free survival

Connect with a study center

  • the Affiliated Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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