Trial Outcomes & Findings for Crohn's Disease Stem Cell Transplantation (NCT NCT00271947)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

baseline

Results posted on

2014-03-27

Participant Flow

enrolled (n=1)

Participant milestones

Participant milestones
Measure	Autologous Stem Cell Transplantation stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Autologous Stem Cell Transplantation stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
Overall Study Lost to Follow-up	1

Baseline Characteristics

Crohn's Disease Stem Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stem Cell Transplantation n=1 Participants stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

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.

Outcome measures

Outcome data not reported

Adverse Events

Stem Cell Transplantation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Richard Burt

Northwestern University

Phone: 312-908-0059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place