UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023343
Receipt number 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 21:16:04

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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 or person

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026894


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name