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| Sponsor: | Richard Burt |
|---|---|
| Information provided by (Responsible Party): | Richard Burt, 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 Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Support in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Phase I Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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 respond to therapy is defined by :
Persistent muscle weakness Grade 3/5 or worse (MRC) in at least one muscle or grade 4/5 in at least two muscle groups
OR
Persistent dysphagia documented by either aspiration or insufficient clearing on video fluoroscopic examination.
OR
Persistent incapacitating sensory loss (e.g. gait ataxia, falls > 1/month)
AND
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: | Richard Burt, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00278629 History of Changes |
| Other Study ID Numbers: | NU FDA CIDP.AUTO2003 |
| Study First Received: | January 16, 2006 |
| Last Updated: | August 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases |