Ensayos clínicos

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