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

Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00953485
• Other study ID #: NJGLYY002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 4, 2009
• Last updated: August 19, 2009
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2009
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Lingyun Sun, MD
• Phone: +86-25-83105219
• Email: lingyunsun2001[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

• 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mesenchymal Stem Cells
• Sjogren's Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	the Affiliated Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sjögren's syndrome disease activity index		Monthly	Yes
Secondary	pSS Serology (ANA, dsDNA, SS-A, SS-B)		Monthly	Yes
Secondary	Improvement of salivary gland function (measured as stimulated saliva flow rate)		Monthly	Yes