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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ

Conditions
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Sjogren's Syndrome, Mesenchymal Stem Cells

Intervention / Treatment
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* Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients fulfilled the international classification criteria (2002) for primary Sjögren's Syndrome, man or woman aged from 15 to 70 years old, Sjögren's Syndrome Disease 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 written informed consent in accordance with the institutional and hospital guidelines. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial and for 12 months following treatment. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment. 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 or harm to nursing infants from this treatment regimen.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)|Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sjögren's syndrome disease activity index |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pSS Serology (ANA, dsDNA, SS-A, SS-B) |  | Monthly | 
| Improvement of salivary gland function (measured as stimulated saliva flow rate) |  | Monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogren's Syndrome, Mesenchymal Stem Cells, Transplantation