Autologous Hair Follicle Derived Mesenchymal Stem Cell Suspension to Treat AGA

NCT05659095 | Completed

• 1 other identifier: NFEC-2020-245
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Androgenic alopecia (AGA) is characterized by progressive hair follicle miniaturization, and novel treatments are needed to intervene in the miniaturization process. The investigators aimed to evaluate the efficacy, safety, effectiveness, and effective population of autologous hair follicle mesenchymal stem cell therapy for the treatment of advanced AGA in Chinese people. 50 participants ranging from 25 to 45 years old, with an average age of 32 ± 1.24 years were included. None of them had ever used minoxidil, finasteride, or other drugs to promote hair growth. Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months. Observers were blinded to patient groupings and measurements.

Conditions

Hair Transplantation

Outcome Measures

Primary Outcomes (1)

• hair diameters changed over time

  hair diameters changed over time

  0 days, 1 month, 3 months, 6 months, and 9 months

Study Arms (2)

Experiment groups

EXPERIMENTAL

Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point.

Other: autologous hair follicle derived mesenchymal stem cell suspension

Control groups

NO INTERVENTION

The control group was injected with the same volume of normal saline.

Interventions

autologous hair follicle derived mesenchymal stem cell suspension OTHER

Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months.

Experiment groups

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of Androgenic alopecia
• AGA classification include：The Norwood grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III

You may not qualify if:

• (1) Using medications or supplements, including finasteride, dutasteride, ketoconazole, minoxidil or any other hormonal products, that can affect hair growth;
• (2) Patients with severe systemic diseases, immune diseases, endocrine diseases and nervous system diseases;
• (3) Patients with head skin infection, allergic disease and malignant tumor

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, 510000, China

Location

Study Officials

• Zhiqi Hu, phD

  southern hosptal

  STUDY CHAIR

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: October 10, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-10

Locations

CN (1)