NCT00282425

Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis

Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Richard Burt, MD · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Scleroderma is disease believed to be due to immune cells, cells which normally protect the body but are now causing damage to the body. There has not been any treatment that has been effective in treating this disease. The likelihood of progression of the disease to severe disability and death is high. This study is designed to examine whether treating patients with high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your immune system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the disease), followed by return of blood stem cells that have been previously collected from patients brother or sister will stop or reverse the disease. The purpose of the Cyclophosphamide, Fludarabine and CAMPATH-1H is to decrease immune system. The purpose of the stem cell infusion is to restore blood production, which will be severely impaired by the Cyclophosphamide, Fludarabine and CAMPATH-1H, and to produce a normal immune system that will no longer attack the body.

Conditions

• Scleroderma

Interventions

Type	Name	Description
BIOLOGICAL	Hematopoietic stem cell transplantation	Allogeneic Hematopoietic stem cell transplantation

Timeline

• Start date: 2005-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2006-01-26
• Last updated: 2012-12-18

Locations

1 site across 1 country: United States