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| Sponsor: | Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00278629 |
Purpose
Chronic inflammatory demyelinating polyneuropathy is disease believed to be due to immune cells, cells which normally protect the body, but are now attacking the nerves in the body. As a result, the affected nerves fail to respond, or respond only weakly, to stimuli causing numbing, tingling, pain, and progressive muscle weakness. The likelihood of progression of the disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing your disease), followed by return of the previously collected blood stem cells will stop the progression of CIDP. 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 high dose cyclophosphamide and ATG is to destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate whether this treatment will produce a normal immune system that will no longer attack the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Polyneuropathy |
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 Chronic Inflammatory Demyelinating Polyneuropathy: A Phase I Trial |
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Failure to therapy defined by (one of the following) (not caused by unrelated conditions):
Exclusion Criteria:
Significant end organ damage such as (not caused by CIDP):
Contacts and Locations| 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: Kathleen Quigley, R.N.;MBA | |
| Sub-Investigator: Kimberly Yaung, R.N. | |
| Principal Investigator: Robert Sufit Sufit, MD | |
| Principal Investigator: | Richard Burt, MD | Northwestern University |
More Information
| Responsible Party: | Northwestern University ( Robert Craig, MD ) |
| Study ID Numbers: | NU FDA CIDP.AUTO2003 |
| Study First Received: | January 16, 2006 |
| Last Updated: | May 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00278629 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Autoimmune Diseases Immune System Diseases Demyelinating Diseases Neuromuscular Diseases |
Polyradiculoneuropathy Peripheral Nervous System Diseases Nervous System Diseases Polyneuropathies Autoimmune Diseases of the Nervous System |