UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020530 |
|---|---|
| Receipt number | R000023683 |
| Scientific Title | Clinical study of treatment for depressed lesions using cultured adipose derived stem cells. |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2020/01/15 09:57:55 |
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Basic information
Public title
Clinical study of treatment for depressed lesions using cultured adipose derived stem cells.
Acronym
Clinical study of treatment for depressed lesions using cultured adipose derived stem cells.
Scientific Title
Clinical study of treatment for depressed lesions using cultured adipose derived stem cells.
Scientific Title:Acronym
Clinical study of treatment for depressed lesions using cultured adipose derived stem cells.
Region
| Japan |
Condition
Condition
depressed lesion
Classification by specialty
| Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to verify efficacy of transplantation of cultured adipose derived cells for depressed lesion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Graft survival rate.
Calcification and cyst formation.
Severity, date, frequency, duration, incidence rate and attribution of adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
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 free fat.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Shimizu |
Organization
University of the Ryukyus Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
207 Uebaru Nisiharacho Nakagamigun, Okinawa
TEL
0988953331
yyssprs@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Shimizu |
Organization
University of the Ryukyus Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
207 Uebaru Nisiharacho Nakagamigun, Okinawa
TEL
0988953331
Homepage URL
yyssprs@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus Hospital
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
Okinawa Science and Technology Promotion Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
琉球大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023683
