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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: 25 March 2024
Main ID:  NCT03449069
Date of registration: 22/02/2018
Prospective Registration: Yes
Primary sponsor: Mayo Clinic
Public title: Pediatric MSC-AFP Sub-study for Crohn's Fistula
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 23, 2018
Target sample size: 1
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT03449069
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
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-aminosalicylate (5-ASA) drugs,
thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (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
Crohn Disease
Fistula in Ano
Intervention(s)
Drug: MSC-AFP
Primary Outcome(s)
Number of participants with treatment-related adverse events (safety and toxicity) [Time Frame: 2 months to approximately at 24 months]
Secondary Outcome(s)
Number of participants with radiographic response to the treatment regarding the treated fistula. [Time Frame: Week 2, Week 8, and Week 24]
Number of participants with response to the treatment regarding cessation of drainage from the treated fistula. [Time Frame: 2 months to approximately at 24 months]
Secondary ID(s)
17-010539
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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