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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10\^6 cells/kg body weight).
the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGSjögren's syndrome disease activity index
Time frame: Monthly
pSS Serology (ANA, dsDNA, SS-A, SS-B)
Time frame: Monthly
Improvement of salivary gland function (measured as stimulated saliva flow rate)
Time frame: Monthly
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