Clinical Trial: Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief Summary:

OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life threatening autoimmune diseases.

II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and posttransplant immunosuppression with cyclosporine in these patients.

III. Determine whether this treatment regimen beneficially influences the clinical course of these patients.

Detailed Summary:

PROTOCOL OUTLINE: Patients receive filgrastim (G-CSF) SC daily until peripheral blood stem cells (PBSC) are collected. On the fifth day of G-CSF therapy, PBSC are collected. Patients undergo plasmapheresis on days -9 to -7. Patients receive cyclophosphamide IV on days -6 to -3 and total lymphoid irradiation on day -1. PBSC are reinfused on day 0. Following PBSC reinfusion, patients receive prophylaxis with oral prednisone or methylprednisolone IV on days -1 to 28, antithymocyte globulin IV on days 1-3, and cyclosporine every 12 hours on days 1-60.

Patients with autoimmune thrombocytopenia purpura, autoimmune hemolytic anemia, or pure red cell aplasia are followed on days 7, 14, 21, 28, 60, and 100, 6 months, and 1, 2, and 5 years. Patients with rheumatoid arthritis, juvenile rheumatoid arthritis, or systemic lupus erythematosus are followed on days 14, 28, 60, and 100, and then every 6 months. Patients with vasculitis are monitored for abnormal clinical and laboratory parameters characteristic of the individual type of vasculitis.

Sponsor: Fairview University Medical Center

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Office of Rare Diseases (ORD)

Dates:
Date Received: July 5, 2000
Date Started: March 2000
Date Completion:
Last Updated: June 23, 2005
Last Verified: October 2003