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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03219359
Date of registration: 13/07/2017
Prospective Registration: Yes
Primary sponsor: Icahn School of Medicine at Mount Sinai
Public title: Autologous Stem Cell Transplant for Crohn's Disease
Scientific title: Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD)
Date of first enrolment: July 12, 2017
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03219359
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Alex Abrahams
Address: 
Telephone: 212-241-8233
Email: alex.abrahams@mssm.edu
Affiliation: 
Name:     Artur Shchukin
Address: 
Telephone: 212-241-0497
Email: artur.shchukin@mssm.edu
Affiliation: 
Name:     Amir Steinberg, MD
Address: 
Telephone:
Email:
Affiliation:  Icahn School of Medicine at Mount Sinai
Name:     Louis Cohen, MD
Address: 
Telephone:
Email:
Affiliation:  Icahn School of Medicine at Mount Sinai
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Crohn's disease by standard criteria

- Active disease based on clinical symptoms, defined as CDAI >250. In patients with an
ostomy, the number of liquid stools score in the CDAI will be replaced by the number
of times that the ostomy bag is emptied daily.

- Active disease based on endoscopic evaluation, defined as SES-CD score > 3 in at least
one bowel segment

- Failure to respond to (or intolerant/adverse reaction to or declines) a member of each
of the class of drugs listed below:

1. corticosteroids

2. azathioprine,

3. 6-mercaptopurine, methotrexate

4. Anti-TNFa (infliximab, adalimumab, certolizumab, golimumab)

5. Anti-integrin agents (natalizumab, vedolizumab)

6. Ustekinumab

- Failure to respond refers to ongoing objective inflammation with symptoms and, as is
traditional, is defined by the gastroenterologist evaluating the patient.

- No surgical therapeutic option secondary to risk of short bowel syndrome or patient
refusal

Exclusion Criteria:

- History of significant toxicity to any medications used in trial (cyclophosphamide,
thymoglobulin, vedolizumab)

- Pregnant or breastfeeding

- Age <18

- Karnofsky Performance Score <60

- Patients who have an uncontrolled infection (presumed or documented) despite
appropriate therapy for at least one month

- Patients with symptomatic coronary artery disease or uncontrolled congestive heart
failure.

- HIV infected

- Ejection fraction <30% or requiring supplemental continuous oxygen.

- DLCO <35% or requiring supplementary oxygen.

- Patients for whom an insufficient number of stem cells (<2 X 10^6/kg) have been
collected.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Cyclophosphamide
Drug: Methylprednisolone
Drug: Thymoglobulin
Drug: Vedolizumab
Procedure: Autologous stem cell transplant
Primary Outcome(s)
Change in Crohn's Disease Activity Index (CDAI) [Time Frame: baseline and 1 year post transplant]
Secondary Outcome(s)
Change in endoscopic activity indices [Time Frame: baseline and 1 year post transplant]
Secondary ID(s)
GCO 17-0378
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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