Stress urinary incontinence of Post-prostatectomy
Conditions
Interventions
Diluted cell solution containing ADRCs will be mixed with adipose tissue after cleansing with lactated ringer, and fill into 10mL syringe. After that, insert (using 18G or most appropriate size needl
Sponsors
Mukouyama Hideki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Patients over the age of 20 (2)Patients with post-prostatectomy stress urinary incontinence who is not able to have effect by medical treatments (3)Post-prostatectomy patients who have not had a recurrence of prostate cancer in two years (4)Patients who have provided a written informed consent to participate in this research (5)Patient who has sufficient amount of adipose in the area of abdomen, lumber, or femoral region. This is to be confirmed by CT Scan (Plain/Supine Position) where adipose is to be collected.
Exclusion criteria
Exclusion criteria: (1)Patients with infectious diseases (2)Patients with fever symptoms (3)Patients with severe complications; heart disease, pulmonary disease, liver disease, kidney disease (creatinine 3.0 and above), bleeding tendency, severe anemia, uncontrolled diabetes, high blood pressure (4)Patients who are currently on a large amount of steroids or immunosuppressive agents (5)Patients with past medical history of drug hypersensitivity (6)Patients with malignant tumors who are receiving chemotherapy, radiation therapy, and other cancer treatments. (7)Patients who are not able to be evaluated properly due to cognitive problems (8)Patients who are carriers of either HBV, HCV, HIV, and HTLV-1 or who are already at onset of the disease.(excluding cured pre-infected patients) (9)Patients who are determined unfit for the treatment by principal investigator or sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety for 52 weeks of post cell transplantation Macroscopic observation (infection, local lesion, presence or absence of tumor mass), observation of general condition | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in urine volumes of a 24 hours pad test in comparison with pre-transplantation value against post transplantation at 4 weeks, 12 weeks, 24 weeks, 52 weeks. (Volume, and decreasing rate) QOL Survey(King Health Questionnaire Sheet) Safety of post transplantation up to 52 weeks | — |
Countries
Japan
Contacts
Public ContactTakamitsu Shimabukuro
Medical Corporation Tokushukai Nanbu Tokushukai Hospital
Outcome results
None listed