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

Not Applicable

• Conditions: Androgenetic alopecia

• Registration Number: JPRN-UMIN000023343
• Lead Sponsor: Tokyo Medical University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-26
• Study Completion: 2019-03-26
• Results First Posted: 2020-03-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified