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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034268
Receipt No. R000039069
Scientific Title Clinical trial of autologous cultured epidermis containing melanocyte (ACE02) in Stable vitiligo or Piebaldism
Date of disclosure of the study information 2018/09/26
Last modified on 2018/10/01

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Basic information
Public title Clinical trial of autologous cultured epidermis containing melanocyte (ACE02) in Stable vitiligo or Piebaldism
Acronym Clinical trial of autologous cultured epidermis containing melanocyte (ACE02) in Stable vitiligo or Piebaldism
Scientific Title Clinical trial of autologous cultured epidermis containing melanocyte (ACE02) in Stable vitiligo or Piebaldism
Scientific Title:Acronym Clinical trial of autologous cultured epidermis containing melanocyte (ACE02) in Stable vitiligo or Piebaldism
Region
Japan

Condition
Condition Stable vitiligo or Piebaldism
Classification by specialty
Dermatology Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify rate of repigmentation of the treatment after autologous cultured epidermis containing melanocyte (ACE02) transplantation.
To evaluate the efficacy and safety for 52 weeks after ACE02 transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Rate of repigmentation for 52 weeks after ACE02 transplantation
Key secondary outcomes Efficacy
1) Rate of repigmentation over time
2) Pattern of repigmentation
3) Color matching
4) Time to reach epithelialization
5) Satisfaction with the treatment
6) Quality of life
7) Presence or absence of melanocytes in basal lamina
8) Presence or absence of melanin production

Safety
1) Number and rate of adverse events and product-related adverse events
2) Number and rate of significant product-related adverse events
3) Number and rate of malfunction in skin graft donor sites
4) Occurrence of product problems

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
Interventions/Control_1 Regenerative medicine:
・ Taking healthy skin
・ Transplantation of autologous cultured epidermis ACE02
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who are aged 12 years or older on the acquisition date of informed consent before clinical study, and who can give a written informed consent
If patients are under 20 years old, patients who can give a written informed consent from proxies
2) Patients diagnosed as vitiligo or piebaldism
3) Patients with stable vitiligo or piebaldism that do not expand or contract for over 12 months
4) Patients without overt Koebner phenomenon for over 12 months
5) Patients who do not develop vitiligo or piebaldism more than 12 months
6) Patients with vitiligo that do not contract after 6 months of treatment by conventional non-surgical treatment ( e.g. Steroid therapy, active-form vitamin D3 therapy, tacrolimus therapy, immunosuppressant drug therapy, PUVA phototherapy, narrowband UVB phototherapy and excimer laser / light phototherapy)
Key exclusion criteria 1) Patients who are under treatment for autoimmune disease (e.g. thyropathy, type I diabetes mellitus, alopecia areata, pernicious anemia, Addison's disease)
2) Patients with systemic administration of steroid (adrenal corticosteroid)
3) Patients with hypersensitivity to antibiotics (penicillin, kanamycin, streptomycin or amphotericin B), or patients with a history of hypersensitivity to penicillin antibiotic and aminoglycoside antibiotic
4) Patients who have allergic reactions to bovine, mouse or swine
5) Patients diagnosed or suspected as cutaneous malignancy or patients with a history of it in these 5 years (among cutaneous malignancy, actinic keratosis is limited to the lesions in skin graft donor sites and site of ACE02 transplantation)
6) Pregnant women, lactating women and patients who may be pregnant, or patients who desire pregnancy during clinical studies
7) At screening time, patients who participated in other clinical trials in the last 6 months
8) Patients who are participating in other clinical studies and patients who are planning to participate in other clinical studies while participating in this clinical study
9) Patients for whom doctors decide as not appropriate to participate in this clinical study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeaki Hayashi
Organization Japan Tissue Engineering Co., Ltd.
Division name Clinical Development Dept.
Zip code
Address 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL 0533-66-2020
Email shigeaki_hayashi@jpte.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Suzuki
Organization Japan Tissue Engineering Co., Ltd.
Division name Clinical Development Dept.
Zip code
Address 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL 0533-66-2020
Homepage URL
Email masami_suzuki@jpte.co.jp

Sponsor
Institute Japan Tissue Engineering Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 09 Month 26 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 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
2018 Year 09 Month 26 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039069

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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