Trial Outcomes & Findings for Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease (NCT NCT01288053)

Last Updated: 2018-08-06

Results Overview

The number of participants who survived treatment

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Up to five years

Results posted on

2018-08-06

Participant milestones
Measure	Allogeneic Stem Cell Therapy Allogeneic Stem Cell Therapy will be performed after conditioning Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Allogeneic Stem Cell Therapy Allogeneic Stem Cell Therapy will be performed after conditioning Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease
Overall Study Death	1

Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease

Baseline characteristics by cohort
Measure	Allogeneic Stem Cell Therapy n=9 Participants Allogeneic Stem Cell Therapy will be performed after conditioning Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.11 years STANDARD_DEVIATION 7.13 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

Timeframe: Up to five years

Population: The number of participants who survived treatment

The number of participants who survived treatment

Outcome measures
Measure	Allogeneic Stem Cell Therapy n=9 Participants Allogeneic Stem Cell Therapy will be performed after conditioning Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease
Survival	8 participants

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events
Measure	Allogeneic Stem Cell Therapy n=9 participants at risk Allogeneic Stem Cell Therapy will be performed after conditioning Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease
Infections and infestations Adenovirus infection	11.1% 1/9 • Number of events 1 • Up to 5 years

Other adverse events
Measure	Allogeneic Stem Cell Therapy n=9 participants at risk Allogeneic Stem Cell Therapy will be performed after conditioning Allogeneic Stem Cell Therapy: Donor stem cells will be given to subject diagnosed with Crohn's disease
Infections and infestations Clostridium difficile infection (C-Diff)	22.2% 2/9 • Number of events 2 • Up to 5 years
Infections and infestations Sinusitis	11.1% 1/9 • Number of events 1 • Up to 5 years
Renal and urinary disorders Acute Kidney Injury	11.1% 1/9 • Number of events 1 • Up to 5 years
Gastrointestinal disorders Anorexia	22.2% 2/9 • Number of events 2 • Up to 5 years
Infections and infestations Strep throat	11.1% 1/9 • Number of events 1 • Up to 5 years
Surgical and medical procedures Cholecystectomy	11.1% 1/9 • Number of events 1 • Up to 5 years
Gastrointestinal disorders perianal abscess	11.1% 1/9 • Number of events 1 • Up to 5 years
Gastrointestinal disorders perforated colon	11.1% 1/9 • Number of events 1 • Up to 5 years
Psychiatric disorders anorexia nervosa	11.1% 1/9 • Number of events 1 • Up to 5 years

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