UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034268 |
|---|---|
| Receipt number | 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 | 2024/02/28 11:34:07 |
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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 | Shigeaki |
| Middle name | |
| Last name | Hayashi |
Organization
Japan Tissue Engineering Co., Ltd.
Division name
Clinical Development Dept.
Zip code
4430022
Address
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL
0533-66-2020
shigeaki_hayashi@jpte.co.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Suzuki |
Organization
Japan Tissue Engineering Co., Ltd.
Division name
Clinical Development Dept.
Zip code
4430022
Address
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL
0533-66-2020
Homepage URL
masami_suzuki@jpte.co.jp
Sponsor or person
Institute
Japan Tissue Engineering Co., Ltd.
Institute
Department
Personal name
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
The IRB of Yamagata University Hospital
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata
Tel
023-628-5840
mebihara@med.id.yamagata-u.ac.jp
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
25
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
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 03 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039069
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