Exosomes for Hairloss Treatment

Early Phase 1

Not yet recruiting

• Conditions: Hair Loss
• Interventions: Biological: exosomes; Other: saline

• Registration Number: NCT06932393
• Lead Sponsor: Guangzhou Bio-gene Technology Co., Ltd

Brief Summary

Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-04-30
• Primary Completion: 2027-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Subjects are able to read documents and can sign informed consent.
2. 18~75 years old (including the threshold), gender is not limited.
3. The subject's "hair loss grade" meets the following criteria:

1. BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or special type (V1 to V3, or F1 to F3); 2) For female: Ludwig Grade I to II. Or for male: Hamilton-Norwood Grade III to IV; 3) Hair density by phototrichogram: ≤ 190 hair/cm² ; 4. Hair dryness ≥ 5%; 5. Until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo.

Exclusion Criteria

1. People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss.
2. Those with a combination of diseases that have an impact on hair growth.
3. Use of medications, medicated shampoos, or hair care products that may interfere with efficacy evaluation within 3 months prior to screening (oral administration of therapeutic agents for androgenetic alopecia must be discontinued for at least 6 months).
4. Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening.
5. Participated or are participating in a interventional clinical trial within 3 months.
6. Persons with a history of hereditary alopecia areata.
7. Women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months.
8. Have undergone hair transplantation in the previous 24 months.
9. Individuals testing positive for active infectious diseases or carriers of communicable pathogens.
10. Those with keloid, keloid-prone or hyperplastic scarring.
11. Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
exosomes	exosomes	Subjects will receive 5E8 \~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase.
saline	saline	The control site will receive the same volume of saline as the exosomes administered in the study site.

Primary Outcome Measures

Name	Time	Method
Comparison of localized hair density	3rd month after 3 treatments	Quantify hair counts within designated 1.5 cm × 1.5 cm fixed areas in both the study area and control area, and compare the localized hair density (hair/cm²) between the two areas.
Safety Assessment	From the initial treatment administration to the subject withdrawal from the study.	Incidence of treatment emergent adverse events (TEAEs)
Comparison of overall hair density	3rd month after 3 treatments	Evaluate and score overall hair density in both the study area and control area using an 8-level assessment scale, followed by a comparative analysis of the two areas.

Secondary Outcome Measures

Name	Time	Method
Change of hair density	3rd and 6st month after 3 treatments	Change in hair density of study area with the baseline.

Trial Locations

Locations (1)

Shenzhen Qianhai Shekou Free Trade Zone Hospital; 🇨🇳 Shenzhen, Guangdong, China