Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy
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|ClinicalTrials.gov Identifier: NCT00278629|
Recruitment Status : Completed
First Posted : January 18, 2006
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyneuropathy||Biological: hematopoietic stem cell transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Trial|
|Actual Study Start Date :||February 21, 2005|
|Actual Primary Completion Date :||January 14, 2017|
|Actual Study Completion Date :||November 4, 2019|
Experimental: Hematopoietic Stem Cell Transplantation in CIDP
Autologous hematopoietic stem cell transplantation will be performed after conditioning regimen of cyclophosphamide 200 mg/kg/intravenously(IV), rATG(thymoglobulin) 5.5 mg/kg/IV and rituximab 1000mg/IV.
Biological: hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation
- Number of Participants With Survival [ Time Frame: up to 5 years ]Survival of participants who survived the treatment and up to 5 years post treatment.
- Disease Improvement - Medication Free Remission [ Time Frame: 6 months, 1, 2, 3, 4 and 5 years post transplant ]Post transplant immune medication-free remission with stable or improving neurological exam
- Disease Improvement - Ambulatory Assistance [ Time Frame: pre transplant, 6 months, 1, 2, 3, 4 and 5 years post transplant ]Disease Improvement - Requires No Assistance to Ambulate
- Change in Disability and Strength Functional Scales [ Time Frame: Pre Transplant, 6 months, 1, 2, 3, 4 and 5 years post transplant ]Change in the Medical Research Council (MRC) Scale: range is 0 (quadriplegic) - 60 (normal).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278629
|United States, Illinois|
|Northwestern University, Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Richard Burt, MD||Northwestern University|