Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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)
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To determine the disease-free survival in pSS patients treated with MSCT in terms of disease activity index, pSS serology and salivary gland function
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To assess adverse events of allogeneic MSC transplantation
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To assess the association of disease activity index, pSS serology levels, and saliva flow rate at baseline with disease-free survival
Study Design
Outcome Measures
Primary Outcome Measures
- Sjögren's syndrome disease activity index [Monthly]
Secondary Outcome Measures
- pSS Serology (ANA, dsDNA, SS-A, SS-B) [Monthly]
- Improvement of salivary gland function (measured as stimulated saliva flow rate) [Monthly]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Stimulated whole saliva flow rate less than 1~6ml/6min.
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Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
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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:
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End-stage renal failure.
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Severe cardiopulmonary compromise, or other system failure.
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Active, uncontrolled infections.
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Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Affiliated Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | 210008 |
Sponsors and Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
- Principal Investigator: Lingyun Sun, MD, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
- Liang J, Zhang H, Hua B, Wang H, Wang J, Han Z, Sun L. Allogeneic mesenchymal stem cells transplantation in treatment of multiple sclerosis. Mult Scler. 2009 May;15(5):644-6. doi: 10.1177/1352458509104590.
- Sun L, Akiyama K, Zhang H, Yamaza T, Hou Y, Zhao S, Xu T, Le A, Shi S. Mesenchymal stem cell transplantation reverses multiorgan dysfunction in systemic lupus erythematosus mice and humans. Stem Cells. 2009 Jun;27(6):1421-32. doi: 10.1002/stem.68.
- Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8.
- Zhou K, Zhang H, Jin O, Feng X, Yao G, Hou Y, Sun L. Transplantation of human bone marrow mesenchymal stem cell ameliorates the autoimmune pathogenesis in MRL/lpr mice. Cell Mol Immunol. 2008 Dec;5(6):417-24. doi: 10.1038/cmi.2008.52.
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