This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc 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 SSc * To determine the disease-free survival in SSc patients treated with MSCT * To assess adverse events of allogeneic MSC transplantation * To assess the association of remission for organ function, clinical score and SSc serology levels 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
RECRUITINGmRSS score,HRQOL score, SF-36 score for SSc patients
Time frame: monthly
Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria
Time frame: every three month
SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4
Time frame: every three month
Change of peripheral blood B and T cells
Time frame: every three month
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