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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012866
Receipt No. 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

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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
Institute Nagoya University Hospital
Institute
Department

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
URL(English) https://upload.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


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