UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012866
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

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Basic information

Public title

Augmentation of soft tissue defect in face, trunk and extremity with adipose-derived regenerative cell enriched lipotransfer.

Acronym

Augmentation of soft tissue defect with adipose-derived regenerative cell enriched lipotransfer.

Scientific Title

Augmentation of soft tissue defect in face, trunk and extremity with adipose-derived regenerative cell enriched lipotransfer.

Scientific Title:Acronym

Augmentation of soft tissue defect with adipose-derived regenerative cell enriched lipotransfer.

Region

Japan


Condition

Condition

Small soft tissue defect in the face, trunk and extremity region

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

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.

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

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.

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuzuru Kamei

Organization

Nagoya University Graduate School of Medicine

Division name

Plastic and Reconstructive Surgery

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2111

Email

joe@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keisuke Takanari

Organization

Nagoya University Graduate School of Medicine

Division name

Plastic and Reconstructive Surgery

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2111

Homepage URL


Email

takanari@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Hospital

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Preinitiation

Date of protocol fixation

2014 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 15 Day

Last modified on

2014 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=R000015012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name