Exosomes for Hairloss Treatment

NCT ID: NCT06932393

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2028-04-30

Brief Summary

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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

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Conditions

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Hair Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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exosomes

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

Group Type EXPERIMENTAL

exosomes

Intervention Type BIOLOGICAL

Each subject will receive 3 injections with an interval of one month.

saline

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

Each subject will receive 3 injections with an interval of one month.

Interventions

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exosomes

Each subject will receive 3 injections with an interval of one month.

Intervention Type BIOLOGICAL

saline

Each subject will receive 3 injections with an interval of one month.

Intervention Type OTHER

Other Intervention Names

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EVs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Bio-gene Technology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Gang Hu, Ph.D. degree

Role: CONTACT

86 15353731762

Zhenping Xie, bachelor's degree

Role: CONTACT

86 15986696889

Facility Contacts

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Jiaqi Zhao

Role: primary

Other Identifiers

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BG-CT-24-007

Identifier Type: -

Identifier Source: org_study_id

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