Exosomes for Hairloss Treatment

Guangzhou Bio-gene Technology

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Hair Loss

Treatments: Other: saline; Biological: exosomes

Study type: Interventional

Funder types: Industry

Identifiers

NCT06932393

BG-CT-24-007

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

exosomes

Experimental group

Description:

Subjects will receive 5E8 \~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase.

Treatment:

Biological: exosomes

saline

Placebo Comparator group

Description:

The control site will receive the same volume of saline as the exosomes administered in the study site.

Treatment:

Other: saline