NCT00953485

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Sjogren's Syndrome
• Mesenchymal Stem Cells

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Mesenchymal Stem Cells (AlloMSC)	Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10\^6 cells/kg body weight).

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-08-06
• Last updated: 2009-08-20

Locations

1 site across 1 country: China