|
Main
|
|
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:
|
16 December 2017 |
|
Main ID: |
NCT03014219 |
|
Date of registration:
|
04/01/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Phase 1 Crohn's Pediatric Sub-study of MSC AFP
|
|
Scientific title:
|
A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study |
|
Date of first enrolment:
|
July 2017 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT03014219 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
William Faubion |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
|
|
Name:
|
Michael C Stephens |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria
1. Males and females 12-17 years of age.
2. Residents of the United States.
3. Crohn's disease with single or multiple draining complex perianal fistulae (definition
as below) for at least three months despite standard therapy (definition below).
4. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics,
and anti-TNF therapy are permitted.
5. All patients should have undergone a colonoscopy in last 12 months to rule out
malignant or premalignant condition
6. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active
metal fragments, claustrophobia
7. Ability to comply with protocol
8. Competent and able to provide written informed consent (and assent where appropriate).
9. Must have failed standard medical therapy including anti-TNF agents
Exclusion Criteria
1. Inability to obtain informed consent (and assent where appropriate).
2. Clinically significant medical conditions within the six months before administration
of MSCs: e.g. sepsis, pneumonia active serious infection or other conditions that
would, in the opinion of the investigators, compromise the safety of the patient.
3. Specific exclusions;
a. Evidence of hepatitis B, C, or HIV
4. History of cancer including melanoma (with the exception of localized skin cancers)
5. Investigational drug within thirty (30) days of baseline
6. A resident outside the United States
7. Pregnant or trying to become pregnant, or breast feeding.
8. History of clinically significant auto-immunity (other than Crohn's disease) or any
previous example of fat-directed autoimmunity
9. Previous allergic reaction to a perianal fistula plug.
10. If adipose tissue is not technically feasible
11. Weight less than 35 kg
12. Allergic to local anesthetics
13. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Perianal Fistula
|
|
Intervention(s)
|
|
Drug: Only 1 arm: treatment with MSC-AFP
|
|
Primary Outcome(s)
|
|
Number of Subjects with any Adverse Events that are related to study drug
[Time Frame: [Time Frame: 2-24 months]
|
|
Secondary Outcome(s)
|
|
Number of Subjects with healing in response to the study drug treatment
[Time Frame: Time Frame: 2-24 months]
|
|
Secondary ID(s)
|
|
15-005574
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|