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The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic therapies will be enrolled. The subjects will be subsequently followed for fistula response and closure for 18 months. This is an autologous product derived from the patient and used only for the same patient.
Visit 1: Patients will be evaluated for eligibility (inclusion/exclusion checklist) and written, informed consent will be obtained. Patients will undergo general exam with vital signs. Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC. In the event there is no cell growth from the tissue obtained from the first biopsy, one further attempt will made from a second tissue sample from this patient. However, if the second attempt fails to grow cells, no further attempts will be made, and the subject will not continue in the study.
Visit 2 (Week 0; Day 0): Patients will undergo an interventional endoscopy, the fistula tract will be assessed and the stem cell coated will be placed endoscopically.
Study visit will be as follows:
Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (week 52; Month 12) Visit 10 (Week 78; Month 18)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC Fistula plug: Single Treatment Group | Experimental | All patients received treatment of a stem cell coated fistula plug. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC Fistula Plug | Drug | Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Data collection will include: worsening of the fistula, abnormal laboratory values, or significant abnormalities in physical examination. The Outcome Measure will be the number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 2-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Fistula Closure | Data collection will include: degree of drainage cessation from fistula. The Outcome Measure will be the number of Participants With Closure of their Fistula. | 2-18 months |
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Inclusion Criteria
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;
a. Evidence of hepatitis B, C, or HIV
Investigational drug within thirty (30) days of baseline
A resident outside the United States
History of clinically significant auto-immunity (i.e. Inflammatory Bowel Disease).
Previous allergic reaction to a fistula plug.
If obtaining sufficient adipose tissue for manufacturing is not technically feasible
Allergic to local anesthetics
Pregnant patients or trying to become pregnant or breast feeding.
Non-enterocutaneous tracts
Fistula output >2000 ml/day
Multiple or end fistulas
Fistulous tract <2 cm in length
Fistulous tract or defect >1 cm in diameter,
Fistulas opening into abdominal wall defect.
Diseased adjacent bowel, fistula in the radiation field, persistent distal obstruction or malignancy
Patients on immunosuppression or chemotherapy
Uncontrolled diabetes, i.e. blood sugar more than 200
Sepsis
Fistulas arising from a malignant lesion
Patients with obstructive malignancies
Patients with stage III and/or stage IV cancers. The investigators will exclude patients with stage III or IV cancers, poorly differentiated cancers and patients with less than accepted disease free surgical margins.
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| Name | Affiliation | Role |
|---|---|---|
| William A Faubion, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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