Ensayos clínicos

Inclusion Criteria

• Males and females 18-65 years of age
• Residents of the United States
• Have a single-tract, transsphincteric anal fistula of cryptoglandular origin
  • Primary fistula (no previous surgical treatment) 
  • Those who have failed previous surgical repairs
• Have no contraindications to MR evaluations
  • Pacemaker
  • Magnetically active metal fragments
  • Claustrophobia
• Ability to comply with protocol
• Competent and able to provide written informed consent

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 (e.g. 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 (i.e. recto-vaginal, entero-vesicular)
• Multi-tract, suprasphincteric and extrasphincteric fistula tract extensions
• Active local infection associated with the fistula