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Crohn's Disease Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00271947
Recruitment Status : Terminated (The PI, who was sponsor got retired)
First Posted : January 4, 2006
Results First Posted : March 27, 2014
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: Autologous Stem Cell Transplantation
Enrollment 1

Recruitment Details enrolled (n=1)
Pre-assignment Details  
Arm/Group Title Autologous Stem Cell Transplantation
Hide Arm/Group Description stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Stem Cell Transplantation
Hide Arm/Group Description stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores
Hide Description Clinical remission defined as a CDAI less than 150 and clinical improvement defined as decline in CDI> or = 70 one year following entry. The participant was not assessed according to the criteria of the outcome measure, because the participant was lost for follow-up.
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Transplantation
Hide Arm/Group Description:
stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description CDAI
 
Arm/Group Title Stem Cell Transplantation
Hide Arm/Group Description stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
All-Cause Mortality
Stem Cell Transplantation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stem Cell Transplantation
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stem Cell Transplantation
Affected / at Risk (%)
Total   0/1 (0.00%) 
Potential participants refused to be randomized. Just one participant was enrolled on study, the study is terminated early.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Richard Burt
Organization: Northwestern University
Phone: 312-908-0059
Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00271947     History of Changes
Other Study ID Numbers: CD Randomized
First Submitted: January 2, 2006
First Posted: January 4, 2006
Results First Submitted: May 8, 2013
Results First Posted: March 27, 2014
Last Update Posted: March 27, 2014