Unique ID issued by UMIN | UMIN000012866 |
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Receipt number | R000015012 |
Scientific Title | Augmentation of soft tissue defect in face, trunk and extremity with adipose-derived regenerative cell enriched lipotransfer. |
Date of disclosure of the study information | 2014/02/20 |
Last modified on | 2014/01/15 23:30:28 |
Augmentation of soft tissue defect in face, trunk and extremity with adipose-derived regenerative cell enriched lipotransfer.
Augmentation of soft tissue defect with adipose-derived regenerative cell enriched lipotransfer.
Augmentation of soft tissue defect in face, trunk and extremity with adipose-derived regenerative cell enriched lipotransfer.
Augmentation of soft tissue defect with adipose-derived regenerative cell enriched lipotransfer.
Japan |
Small soft tissue defect in the face, trunk and extremity region
Plastic surgery |
Others
NO
Patients with soft tissue defect in head and neck, trunk and extremity due to tumor resection or hemifacial atrophy and other congenital deformity present problems in their psychological and social quality of life. The current standard treatment is a lipotransfer, which enclose a critical issue such as low graft survival rate and uncertain outcome. Lipotransfer with adipose derived stem cells (cell assisted lipotransfer, CAL) has a promising potential to overcome these problems and has been shown to improve graft survival rate. There are several clinical trials that focus on the patients after mastectomy.
In the current study, our group intends to examine the efficacy as well as safety of CAL in the patients with the soft tissue defect in face, trunk and extremity region.
Safety,Efficacy
Confirmatory
Phase I,II
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.
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.
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Historical
1
Treatment
Other |
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 (1 x 10^6-8 / 5 ml). Stem cell suspension and free fat will be mixed (1:1) and injected into the defect.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Yuzuru Kamei |
Nagoya University Graduate School of Medicine
Plastic and Reconstructive Surgery
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-2111
joe@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Keisuke Takanari |
Nagoya University Graduate School of Medicine
Plastic and Reconstructive Surgery
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-2111
takanari@med.nagoya-u.ac.jp
Nagoya University Hospital
Nagoya University Hospital
Other
NO
2014 | Year | 02 | Month | 20 | Day |
Unpublished
Preinitiation
2014 | Year | 01 | Month | 10 | Day |
2014 | Year | 03 | Month | 10 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015012
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