Crohn's Disease Stem Cell Transplantation

This study has been terminated.
(The PI, who was sponsor got retired)
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier:
NCT00271947
First received: January 2, 2006
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Biological: Autologous Stem Cell Transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
enrolled (n=1)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Autologous Stem Cell Transplantation stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen

Participant Flow:   Overall Study
    Autologous Stem Cell Transplantation  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stem Cell Transplantation stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.

Baseline Measures
    Stem Cell Transplantation  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores   [ Time Frame: baseline ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Potential participants refused to be randomized. Just one participant was enrolled on study, the study is terminated early.  


Results Point of Contact:  
Name/Title: Dr Richard Burt
Organization: Northwestern University
phone: 312-908-0059 ext N/A
e-mail: rburt@northwestern.edu


No publications provided


Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00271947     History of Changes
Other Study ID Numbers: CD Randomized
Study First Received: January 2, 2006
Results First Received: May 8, 2013
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration