Small soft tissue defect in the face, trunk and extremity region
Conditions
Interventions
Adipose tissue will be harvested from abdominal region. The tissue will be processed by cell processing device (Celution : Cytori Therapeutics, Inc.) and adipose derived stem cells will be harvested (
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient inclusion criteria will be as follows; 1. Patients who underwent radical resection and reconstruction due to tumor in face, trunk and extremity, is free from recurrence, metastasis, and has soft tissue defect more than 1year after operation. 2. Patients with congenital facial atrophy or mammary grand defect. 3. Patients with congenital or acquired facial nerve palsy who received treatment of reconstruction more than 1 year ago and still have soft tissue defect. 4. Fulfill one of above criteria and the defect is estimated to be 10 to 200 ml. 5. The patients included in the study should understand advantages, disadvantages and complication of the treatment and is willing to receive stem cell treatment.
Exclusion criteria
Exclusion criteria: The exclusion criteria will be as follows; 1. Patients failed to receive informed consent. 2. Patients who is considered to live less than 1 year due to other complications. 3. Patients who has or has a history of malignant tumor in 5 years. Or patients who is evaluated to possess malignant tumor by other examinations. 4. Patients who possess severe inflectional disease or is positive for WR-a, HCV, HB, or HIV. 5. Patients with severe hepatic or renal disorders. 6. Patients with leucopenia, thrombocytopenia, or other severe hematopoietic disorders or severe anemia. 7. Patients with pregnancy or possible pregnancy. 8. Other situation with which medical doctor decide to abort inclusion of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT, MRI and US will be taken to examine objective outcomes. CT and MRI will be utilized to assess volumetric change and US will be utilized to assess volumetric and elastic change. Also, the standardized photograph will be taken to assess the change in appearance. Time points will be pre-treatment, 2 weeks, and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the treatment and following every 6 months up to 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL score will be retrieved pre-treatment, 2 weeks, and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the treatment and following every 6 months up to 5 years. SF-36 will be utilized to assess QOL outcome. | — |
Countries
Japan
Contacts
Public ContactKeisuke Takanari
Nagoya University Graduate School of Medicine Plastic and Reconstructive Surgery
Outcome results
None listed