Fistula caused by infectious complications after Gastrointestinal Surgery
Conditions
Interventions
Adipose Derived Regenerative Cell
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient with fistula after gastrointestinal surgery refractory to conventional therapy at least one month 2)Measurable Fistula by CT, MRI, radiologic contrast study and/or endoscopy 3)fistula volume 10ml 4)Age 20-75 years and less 5)Body weight 40kg and more 6)Normal cardiac function 7)The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 to 1 8)Vital organ functions listed below are preserved prior to entry 1. WBC 4,000 /mm3 and over 2. Hemoglobin 9.0 g/dl and over 3. Platelet 100,000 /mm3 and over 4. Total bilirubin 1.5 ml/dl and less 5. AST and ALT 100 IU/l and less 6. Creatinine 1.5 mg/dl and less 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with cancer 2)Any anti-cancer therapy 3)Gastrointestinal obstruction 4)Active infection 5)Serious comorbid disease (such as cardiovascular , pulmonary, liver, renal, hemorrhagic diesases, uncontrollable diabetes mellitus or hypertension) 6)Anticoagulation or antiplatelets therapy 7)History of prior drug allergy 8)Pregnant women, possibly pregnant women, and nursing mothers 9)Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, type, severity, and duration of adverse events | — |
Countries
Japan
Contacts
Public ContactTsunekazu Mizushima
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed