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Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00953485
Study type Interventional
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Lingyun Sun, MD
Phone +86-25-83105219
Email lingyunsun2001@yahoo.com.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date June 2009
Completion date December 2011

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