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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03220243 |
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Date of registration:
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14/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Stem Cell Coated Fistula Plug in Patients With Crohn's RVF
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Scientific title:
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A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Rectovaginal Fistulizing Crohn's Disease |
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Date of first enrolment:
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October 19, 2017 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03220243 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Amy L Lightner |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Females 18-65 years of age.
2. Residents of the United States.
3. Crohn's disease with single or multiple draining complex rectovaginal fistulae for at
least three months despite standard therapy
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
9. Must have failed standard medical therapy including anti-TNF agents
10. Currently with diverting ileostomy or accepting of diverting ileostomy at time of stem
cell loaded plug placement.
Exclusion Criteria
1. Inability to give informed consent.
2. Clinically significant medical conditions within the six months before administration
of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other
conditions that would, in the opinion of the investigators, compromise the safety of
the patient.
3. Specific exclusions; 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 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. Allergic to local anesthetics
11. Pregnant patients or trying to become pregnant.
12. entero-vesicular or multiple concurrent perianal tracts
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Fistula Vagina
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Intervention(s)
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Drug: MSC-AFP
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Primary Outcome(s)
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Number of participants with treatment-related adverse events (safety and toxicity).
[Time Frame: 0-24 months]
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Secondary Outcome(s)
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Number of participants with response to the treatment regarding potential cessation of drainage from their fistula.
[Time Frame: 3-24 months]
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Secondary ID(s)
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17-002892
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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