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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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