Umbilical Cord-derived Mesenchymal Stem Cell Exosomes on Hair Growth in Patients With Androgenetic Alopecia

NCT ID: NCT06697080

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2024-12-28

Brief Summary

A total of 50 patients with androgenetic alopecia were selected for the study. Patients who met the inclusion/exclusion criteria were randomly assigned to groups A and B in a 1:1 ratio to receive treatment, with the enrollment date designated as Day 1. Group A visited the clinic once each in the first, second, and third months for treatment with exosomes, while Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes. At the time points of 1, 2, 3, and 6 months after the start of the treatment period, dermatoscopic examinations were conducted on patients in both groups. The differences in hair growth density, hair shaft thickness, and follicle counts within a 1 cm diameter area were compared between the two groups. Additionally, the data differences for each subject at baseline and at the end of the experiment were also assessed.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Group A

Group A visited the clinic once each in the first, second, and third months for treatment with exosomes

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells

Intervention Type: DRUG

Human umbilical cord mesenchymal stem cells

Group B

Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes.

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells

Intervention Type: DRUG

Human umbilical cord mesenchymal stem cells

Interventions

Human umbilical cord mesenchymal stem cells

Human umbilical cord mesenchymal stem cells

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:Clinical diagnosis of Androgenic alopecia · AGA classification include：The No grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III Exclusion Criteria: (1) Using medications or supplements, including finasteride, dutasteride, minoxidil or any other hormonal products, that can affect hair growth; · (2) Patients with severe diseases, immune diseases, endocrine diseases and nervous system diseases; (3) Patients with infection, allergic disease and malignant tumor

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Plastic and Aesthetic Surgery, Nanfang Hospital Southern 8 Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFEC-2024-323

Identifier Type: -

Identifier Source: org_study_id