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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00278642 |
Autoimmune Bullous Skin Disorders are believed to be due to immune cells, cells that normally protect the body and are now causing damage to the body.
This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) together with anti-thymocyte globulin (a protein that kills the immune cells that are thought to be causing your disease), followed by return of the previously collected special blood cells (stem cells) will result in improvement of this disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this skin disease. The purpose of the stem cell infusion is to restore the body's blood production, which will be severely impaired by the high dose chemotherapy and anti-thymocyte globulin.
Condition | Intervention | Phase |
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Pemphigus |
Procedure: Hematopoietic stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders: A Phase I Trial |
Estimated Enrollment: | 20 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
An established diagnosis of an autoimmune skin disorder that includes any of the following:
Diagnosis of bullous skin lesions will be based on history and physical, skin biopsy (light microscopy and indirect fluorescence), indirect immunofluorescence titer, BP 180 and 230 titers, Desmolglein-3 and Desmoglein-1 antibody, and photograph.
Patients who failed corticosteroids (equivalent dosage of prednisone 0.5 mg/kg/day for more than 3 months), and at least two of the following:
azathioprine, mycophenolate mofetil, gold, tetracycline (or minocycline), cyclosporin, methotrexate, gold, or plasmapheresis. Failure is defined as the inability to wean steroids to less than 0.5 mg/kg/day.
Exclusion Criteria:
Significant end organ damage such as:
Contact: Dzemila Spahovic, MD | 312-908-0059 | d-spahovic@northwestern.edu |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Richard Burt, MD | |
Sub-Investigator: Joan Guitart, MD | |
Sub-Investigator: Kathleen Quigley, R.N.;M.B.A. | |
Sub-Investigator: Kimberly Yaung, R.N. |
Principal Investigator: | Richard Burt, MD | Northwestern University |
Responsible Party: | Northwestern University ( Richard Burt, MD ) |
Study ID Numbers: | DIAD Derm.Auto2001 |
Study First Received: | January 16, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00278642 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Skin Diseases, Vesiculobullous Skin Diseases Cyclophosphamide Pemphigus |
Autoimmune Diseases Immune System Diseases Skin Diseases, Vesiculobullous Skin Diseases Pemphigus |