UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023343
Receipt No. R000026894
Scientific Title Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Date of disclosure of the study information 2016/07/26
Last modified on 2020/06/01 (Ver. 5)

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Basic information
Public title Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Acronym Clinical research study of autologous DSCC
Scientific Title Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Scientific Title:Acronym Clinical research study of autologous DSCC
Region
Japan

Condition
Condition Androgenetic alopecia
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of human autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phototrichogram of injection site, vital signs, and adverse events until 12 month after injection.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Higher cell concentration
Interventions/Control_2 Intermediate cell concentration
Interventions/Control_3 Lower cell concentration
Interventions/Control_4 Placebo
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients must meet all the following inclusion criteria to enroll into the study:
1. Male or female of 20 year old or more with in good health having androgenetic alopecia involving the vertex area of the scalp.
2. Males patients with androgenetic alopecia characterized as type III vertex type to type VI on the Norwood Scale. Female patients with androgenetic alopecia characterized as vertex pattern type 3 to type 6 of the Shiseido Scale.
3. Person with willingness to provide written informed consent for participation in the study, to attend all study visits and to complete all procedures required by this protocol.
4. The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation and scars that may confound study results.
5. Person with willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study.
Key exclusion criteria The presence of any of the following will exclude a subject from study enrolment:
1. Use of any product (medication or otherwise) which interferes with the hair growth cycle.
2. Any systemic medical treatment for hair loss within the last 3 months.
3. Start of contraception treatments of oral contraceptives within the last 3 months.
4. Women who are pregnant or nursing and wish to get pregnant in clinical study period.
5. Presence of any medical condition that influences the hair growth cycle.
6. Infection has been confirmed by virological examination and syphilis testing carried out at the time of the screening.
7. Subjects diagnosed with cancer with or without chemotherapy treatment.
8. Sudden hair loss within the last 3 months unrelated to normal seasonal hair shedding or androgenetic alopecia.
9. Subjects in the process of or having completed surgical correction of hair loss in the past 24 months.
10. History of hypersensitivity has been confirmed by application of local anesthetic.
11. A lot of gray hair of the test areas (areas to be injected).
12 Investigator or the sharing researcher has determined to be inappropriate as a target.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name Ryoji
Middle name
Last name Tsuboi
Organization Tokyo Medical University Hospital
Division name Department of Dermatology
Zip code 160-0023
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan
TEL 03-3342-6111
Email tsuboi@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Takahira
Organization SRD Co., Ltd
Division name Data Science Department
Zip code 104-0032
Address RBM kyobashi Bldg., 3-4-8, Hatchobori, Chuo-ku, Tokyo, 104-0032, Japan
TEL 03-5543-0296
Homepage URL
Email m-takahira@cro-srd.co.jp

Sponsor
Institute Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Dermatology, Toho University Ohashi Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo medical university certified special committee for regenerative medicine
Address 6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel 03-3342-6111
Email Regn_IRB@tokyo-med.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
2016 Year 07 Month 26 Day

Related information
URL releasing protocol https://www.jaad.org/article/S0190-9622(20)30272-3/abstract
Publication of results Published

Result
URL related to results and publications https://www.jaad.org/article/S0190-9622(20)30272-3/abstract
Number of participants that the trial has enrolled 67
Results 
Fifty men and 15 women aged 33 to 64 years were injected with DSC cells. Total hair density and cumulative hair diameter at the 300,000 DSC cells injection site was significantly increased compared with the placebo after 6 and 9 months. Men and women showed similar improvements, and there were no serious adverse events.
Results date posted
2020 Year 06 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 03 Month 05 Day
Baseline Characteristics 
Men and women older than 20 years with MPHL and FPHL.
Participant flow 
A total of 67 participants were selected and　received biopsies, and 65 participants (50 men and　15 women were injected with autologous DSC　cells (FAS).　 A total of　62 participants completed the 12-month observation　period (PPS).
Adverse events 
Mild adverse events, such as erythema, swelling, purpura, and small hemorrhages, at the injection sites were observed in 14 cases (45 by sites). Three mild vagal reflexes were seen at the time of injection as systemic adverse events. These local and systemic adverse events were mild and occurred during the injection, after which their disappearance was confirmed.
Outcome measures 
The difference of total hair density (v.s. Placebo, number/cm2)
6 month: 2.6 [1.1]
9 month: 3.6 [1.1]
The difference of cumulative hair diameter (v.s. Placebo, mm/cm2)
6 month: 0.095 [0.002]
9 month: 0.133 [0.002]
Mean difference [95% WaldCI]
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 24 Day
Date of IRB
2016 Year 05 Month 31 Day
Anticipated trial start date
2016 Year 07 Month 12 Day
Last follow-up date
2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 26 Day
Last modified on
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026894