Exosomes for Hairloss Treatment

NCT06932393 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BG-CT-24-007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Loss

Keywords

Hair Loss; Exosomes

Outcome Measures

Primary Outcomes (3)

• Comparison of localized hair density

  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.

  3rd month after 3 treatments

• Safety Assessment

  Incidence of treatment emergent adverse events (TEAEs)

  From the initial treatment administration to the subject withdrawal from the study.

• Comparison of overall hair density

  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.

  3rd month after 3 treatments

Secondary Outcomes (1)

• Change of hair density

  3rd and 6st month after 3 treatments

Study Arms (2)

exosomes

EXPERIMENTAL

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

Biological: exosomes

saline

PLACEBO COMPARATOR

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

Other: saline

Interventions

exosomes BIOLOGICAL

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

Also known as: EVs

exosomes

saline OTHER

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

saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss.
• Those with a combination of diseases that have an impact on hair growth.
• 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).
• Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening.
• Participated or are participating in a interventional clinical trial within 3 months.
• Persons with a history of hereditary alopecia areata.
• Women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months.
• Have undergone hair transplantation in the previous 24 months.
• Individuals testing positive for active infectious diseases or carriers of communicable pathogens.
• Those with keloid, keloid-prone or hyperplastic scarring.
• Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead

Study Sites (1)

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, 518067, China

Location

MeSH Terms

Conditions

Alopecia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Gang Hu, Ph.D. degree

CONTACT

86 15353731762; hugangxa@163.com

Zhenping Xie, bachelor's degree

CONTACT

86 15986696889; 2279054857@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CN (1)