A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes (MSCs treatment)

Southern University of Science and Technology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Androgenic Alopecia

Treatments: Drug: Human umbilical cord mesenchymal stem cell exosomes; Drug: Minoxidil 5% Topical Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07203599

LL-KY-2024218-04

Details and patient eligibility

About

This clinical trial aims to determine the efficacy of human umbilical cord mesenchymal stem cell exosomes (hUCMSC-sEV) in treating androgenic alopecia in young men. It will also investigate the safety of hUCMSC-sEV. The primary inquiry it seeks to address is:

• Do hUCMSC-sEV demonstrate efficacy in the treatment of androgenic alopecia in young men?
• Do hUCMSC-sEV safely used to treat androgenic alopecia in young men?

The clinical trial has two parts. The Phase I study is a dose-escalation trial. Researchers will determine the appropriate dosage of hUCMSC-sEV. The Phase II study is a randomized controlled trial. Researchers will evaluate hUCMSC-sEV against a placebo (minoxidil tincture) to determine the efficacy of hUCMSC-sEV in treating androgenic alopecia in young men.

In the phase I study, participants will be categorized into three dosage groups: A, B, and C. In Group A, one injection site will be allocated for each 1 cm² of hair loss area, delivering a dosage of 1.0×10^8 particles per site. In Group B, the dosage will be 1.0×10^9 particles per site. In Group C, the dosage will be 1.0×10^10 particles per site. Participants will attend the clinic at weeks 0, 2, 4, and 6 for treatment and assessments. Participants will also attend the clinic for follow-up examinations at weeks 8, 12, and 24.

In the phase II study, participants will be randomly allocated in a 1:1 ratio to two groups: the hUCMSC-sEV treatment group and the minoxidil treatment group. hUCMSC-sEV treatment group: the appropriate dose of hUCMSC-sEV for the phase II study was determined based on assessments of safety, tolerability, and preliminary efficacy from the phase I study. Participants will receive one injection site for each 1 cm² of hair loss area. Participants will attend the clinic for therapy and assessments at weeks 0, 2, 4, and 6. Minoxidil treatment group: participants will get 1 mL of minoxidil administered daily to the area of hair loss for 12 consecutive weeks. All patients will attend the clinic for follow-up examinations at weeks 8, 12, and 24.

Enrollment: 59 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Male patients aged 18-35 2. Clinically diagnosed with androgenic alopecia, Hamilton Norwood Scale III-V 3. Patients who voluntarily participate in clinical trials and sign informed consent forms

Exclusion criteria

• 1. Known alcohol allergy 2. Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic system 3. Patients with other scalp diseases or hair loss diseases 4. Patients with severe mental illness and cognitive impairment 5. Patients with poor nutritional status and low immune function 6. Within 1 year, those who have used systemic corticosteroids, immunosuppressants, cytotoxic drugs, and peripheral vasodilators 7. Within 6 months, those who have used systemic or local drugs to treat hair loss, such as finasteride, minoxidil, etc 8. Within 3 months, those who have received other clinical trial drugs 9. Family genetic history or other criteria considered unsuitable by researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 5 patient groups

Group A

Experimental group

Description:

Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^8 particles of hUCMSC-sEV per site.

Treatment:

Drug: Human umbilical cord mesenchymal stem cell exosomes

Group B

Experimental group

Description:

Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^9 particles of hUCMSC-sEV per site.

Treatment:

Drug: Human umbilical cord mesenchymal stem cell exosomes

Group C

Experimental group

Description:

Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^10 particles of hUCMSC-sEV per site.

Treatment:

Drug: Human umbilical cord mesenchymal stem cell exosomes

hUCMSC-sEV treatment group

Experimental group

Description:

Participants will receive one injection site for each 1 cm² of hair loss area with the optimal dose of hUCMSC-sEV.

Treatment:

Drug: Human umbilical cord mesenchymal stem cell exosomes

Minoxidil treatment group

Active Comparator group

Description:

Participants will get 1 mL of minoxidil administered daily to the area of hair loss.

Treatment:

Drug: Minoxidil 5% Topical Solution