A Study of the Safety and Effectiveness of Stem Cell Fistula Plugs to Repair Post Surgical Leak Fistulas
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004326
NCT ID: NCT02807389
Sponsor Protocol Number: 15-004326
About this study
The purpose of this study is to assess the safety and effectiveness of a Stem cell transfer using a biomatrix (The Gore Fistula Plug) in patients with persistent symptoms of post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic treatments. The subjects will be 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 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
- Have a 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.)
Exclusion Criteria
- Inability to give informed consent
- Clinically significant medical conditions within the six months before administration of MSCs
- Myocardial infarction
- Active angina
- Congestive heart failure
- Other conditions that would in the opinion of the investigators compromise the safety of the patient
- 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
- Obtaining sufficient adipose tissue for manufacturing is not technically feasible
- Allergic to local anesthetics
- Pregnant patients, 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
- Malignancy
- On immunosuppression or chemotherapy
- Uncontrolled diabetes, i.e. blood sugar more than 200
- Sepsis
- Fistulas arising from a malignant lesion
- Have obstructive malignancies
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator William Faubion, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available