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Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.

Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia. - Clinical research study of autologous DSCC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023343
Enrollment
66
Registered
2016-07-26
Start date
2016-07-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic alopecia

Interventions

Higher cell concentration Intermediate cell concentration Lower cell concentration Placebo

Sponsors

Tokyo Medical University Hospital
Lead Sponsor
Department of Dermatology, Toho University Ohashi Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Phototrichogram of injection site, vital signs, and adverse events until 12 month after injection.

Countries

Japan

Contacts

Public ContactManabu Takahira

SRD Co., Ltd Data Science Department

m-takahira@cro-srd.co.jp03-5543-0296

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026