Sjogren's Syndrome Clinical Trial
Official title:
Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ
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.
- 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
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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