Hair LossEarly Phase 1NCT06932393
Exosomes for Hairloss Treatment
A Early Phase 1 study testing exosomes and saline in people with Hair Loss, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hair Loss
- What is being tested?
- exosomes and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 17 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are able to read documents and can sign informed consent.
- 18~75 years old (including the threshold), gender is not limited.
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, 518067
About this study
Official title: A Randomized, Double-blind, Single-center, Self-controlled Exploratory Clinical Study of Exosomes for Hairloss Treatment
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
- Being tested
- exosomes, saline
- Keywords
- Hair Loss, Exosomes
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomesBiological
Also called EVs
Each subject will receive 3 injections with an interval of one month.
salineOther
Each subject will receive 3 injections with an interval of one month.
| Study group | Role | What they receive |
|---|---|---|
| exosomes | Experimental | Subjects will receive 5E8 ~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase. Receives: Biological: exosomes |
| saline | Placebo comparator | The control site will receive the same volume of saline as the exosomes administered in the study site. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd month after 3 treatments
Safety Assessment
Incidence of treatment emergent adverse events (TEAEs)
Measured: 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.
Measured: 3rd month after 3 treatments
Secondary outcomes (1)
Change of hair density
Change in hair density of study area with the baseline.
Measured: 3rd and 6st month after 3 treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start30 Apr 2025
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Why it stopped: Per updated regulatory requirements, the site is ineligible to proceed. The clinical institution office has terminated the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932393
- Sponsor's protocol ID
- BG-CT-24-007
- Status last verified
- May 2026
- First submitted
- 9 Apr 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-center, Self-controlled Exploratory Clinical Study of Exosomes for Hairloss Treatment
- ClinicalTrials.gov ID
- NCT06932393
- Acronym / sponsor ID
- BG-CT-24-007
- Conditions
- Hair Loss
- Keywords
- Hair Loss, Exosomes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per updated regulatory requirements, the site is ineligible to proceed. The clinical institution office has terminated the project.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exosomes | Experimental | Biological: exosomesSubjects will receive 5E8 ~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase. |
| saline | Placebo comparator | Other: salineThe control site will receive the same volume of saline as the exosomes administered in the study site. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are able to read documents and can sign informed consent.
- 18~75 years old (including the threshold), gender is not limited.
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomesAlso: EVsEach subject will receive 3 injections with an interval of one month. | Biological | exosomes |
| salineEach subject will receive 3 injections with an interval of one month. | Other | saline |
Primary outcome
Comparison of localized hair density
Time frame: 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
Time frame: From the initial treatment administration to the subject withdrawal from the study.
Incidence of treatment emergent adverse events (TEAEs)
Comparison of overall hair density
Time frame: 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.
1 secondary outcome
Change of hair density
Time frame: 3rd and 6st month after 3 treatments
Results and safety
The study was stopped early (reason given: Per updated regulatory requirements, the site is ineligible to proceed. The clinical institution office has terminated the project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hair Loss
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Active, not recruiting
Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir and Topical 5% Minoxidil
Scalp Health, Alopecia
Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Androgenic Alopecia, Hair Loss/Baldness
Recruiting
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Alopecia, Chemotherapy-induced Alopecia
Not yet recruitingObservational study
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Gut Dysbiosis, Telogen Effluvium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing exosomes and saline in people with Hair Loss, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per updated regulatory requirements, the site is ineligible to proceed. The clinical institution office has terminated the project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of localized hair density (time frame: 3rd month after 3 treatments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.