Stem Cell Fistula Plug in Perianal Crohn's Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Crohns Disease |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/1/2019 |
| Start Date: | July 2013 |
| End Date: | March 2020 |
A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of
20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated
perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard
adjuvant therapy including drainage of infection and placement of a draining seton with
continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining
seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per
current clinical practice. The subjects will be subsequently followed for fistula response
and closure for 24 months. This is an autologous product derived from the patient and used
only for the same patient.
using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of
20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated
perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard
adjuvant therapy including drainage of infection and placement of a draining seton with
continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining
seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per
current clinical practice. The subjects will be subsequently followed for fistula response
and closure for 24 months. This is an autologous product derived from the patient and used
only for the same patient.
Inclusion Criteria
- Males and females 18-65 years of age.
- Residents of the United States.
- Crohn's disease with single or multiple draining complex perianal fistulae (definition
as below) for at least three months despite standard therapy (definition below).
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics,
and anti-TNF therapy are permitted.
- All patients should have undergone a colonoscopy in last 12 months to rule out
malignant or premalignant condition
- Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active
metal fragments, claustrophobia
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Must have failed standard medical therapy including anti-TNF agents
Exclusion Criteria
- Inability to give informed consent.
- 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.
- Specific exclusions: Evidence of hepatitis B, C, or HIV
- History of cancer including melanoma (with the exception of localized skin cancers)
- Investigational drug within thirty (30) days of baseline
- A resident outside the United States
- Pregnant or breast feeding.
- History of clinically significant auto-immunity (other than Crohn's disease) or any
previous example of fat-directed autoimmunity
- Previous allergic reaction to a perianal fistula plug.
- If liposuction is not technically feasible
- Allergic to local anesthetics
- Pregnant patients or trying to become pregnant.
- Non-enterocutaneous tracts (ie recto-vaginal, entero-vesicular)
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: William A Faubion, MD
Phone: 507-284-0495
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