NCT00962923

Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

• 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 – 65 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 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.

Detailed description

* 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

Conditions

• Systemic Sclerosis
• 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: 2009-08-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-08-20
• Last updated: 2009-08-20

Locations

1 site across 1 country: China