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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020530
Receipt No. 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

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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
Email 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
Email yyssprs@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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