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

NCT06697080 | Active Not Recruiting

• 1 other identifier: NFEC-2024-323
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• hair diameters changed over time

  hair diameters changed over time

  0 days, 1 month, 3 months, 6 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Human umbilical cord mesenchymal stem cells

Group B

EXPERIMENTAL

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

Drug: Human umbilical cord mesenchymal stem cells

Interventions

Human umbilical cord mesenchymal stem cells DRUG

Human umbilical cord mesenchymal stem cells

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: June 28, 2024
• Primary Completion: September 28, 2024
• Study Completion: December 28, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)