Stem Cell Fistula Plug in Post Surgical Leak Fistulas
Completed · Phase 1
Conditions studied: Surgical Leak Fistula
In brief
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.
Key facts
- Study ID
- NCT02807389
- Run by
- Mayo Clinic
- People needed
- 2
- Starts
- 2017-03-14
- Expected to finish
- 2019-04-02
- Last updated by the study team
- 2019-04-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females 18-75 years of age.
- Residents of the United States.
- Patients with persistent symptomatic fistulas arising after gastro-esophageal resections, enteric or colonic resections or Bariatric surgeries.
- Single-tract fistula
- Have no contraindications to imaging evaluations: e.g. contrast allergies
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Must have failed standard conservative therapy which includes at least one endoscopic attempt to resolve fistula. Standard conservative management includes drainage of sepsis, antibiotics, nutritional support, etc. Endoscopic closure attempt with devices such as, but not limited to; endo-stitch, clipping, surgical sealants, etc. This attempt may be with or without diversion of the luminal contents by stenting.
- Radiographic Imaging within 7 days of fistula plug placement (e.g. CT, PET, etc.).
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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