depressed lesion
Conditions
Interventions
After a small amount of fat is harvested from the patient, adipose derived stem cells (ADSCs) is extracted at Cell Processing Center. The ADSCs are cultured and injected into the depressed lesion with
Sponsors
University of the Ryukyus Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)patients with congenital or acquired depressed lesion in which fat grafting is suggested. (Breast deficit after breast cancer, traumatic tissue defects, hemifacial atrophy, facial muscle atrophy after facial palsy, enophthalmos due to anophthalmia, funnel chest, etc.) 2)patients with depressed lesion who undergo secondary revision surgery with fat grafting. 3)In case of secondary revision surgery, at least three months should be passed after first surgery. 4)Informed consent should be obtained. 5)patients must be at least 10 years old without serial illness. 6)patients who live in Okinawa prefecture at least 6 months after the clinical study. 7)patients who undergo another clinical study 'Development of extraction system of safe and good quality adipose derived stem cells' may be included if they qualify above mentioned inclusion criteria.
Exclusion criteria
Exclusion criteria: 1)pregnant patients. 2)patients with the risk of recurrence or metastasis of malignant tumor 3)patients who take anti-cancer agent or immunosuppressive agent 4)patients with local infection in or near the depressed lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized photograph will be taken to assess the change the recovery rate of depressed lesion. Time points will be pre-treatment, 1 week, and 1,3,6 months after the treatment. Also, computed tomography scan will be taken to assess the volumetric change pre- and post 6 months operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Graft survival rate. Calcification and cyst formation. Severity, date, frequency, duration, incidence rate and attribution of adverse events. | — |
Countries
Japan
Contacts
Public ContactYusuke Shimizu
University of the Ryukyus Hospital Department of Plastic and Reconstructive Surgery
Outcome results
None listed