Androgenic AlopeciaNCT06697080
Umbilical Cord-derived Mesenchymal Stem Cell Exosomes on Hair Growth in Patients With Androgenetic Alopecia
A study testing Human umbilical cord mesenchymal stem cells in people with Androgenic Alopecia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
A total of 50 patients with androgenetic alopecia were selected for the study. Patients who met the inclusion/exclusion criteria were randomly assigned to groups A and B in a 1:1 ratio to receive treatment, with the enrollment date designated as Day 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Human umbilical cord mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Clinical diagnosis of Androgenic alopecia · AGA classification include：The No grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III Exclusion Criteria: (1) Using medications or supplements, including finasteride, dutasteride, minoxidil or any other hormonal products, that can affect hair growth; · (2) Patients with severe diseases, immune diseases, endocrine diseases and nervous system diseases; (3) Patients with infection, allergic disease and malignant tumor
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Plastic and Aesthetic Surgery, Nanfang Hospital Southern 8 Medical University
Guangzhou, Guangdong
About this study
Official title: A Randomized-controlled Clinical Trial to Treat Chinese Advanced AGA With Umbilical Cord-derived Mesenchymal Stem Cell Exosomes
A total of 50 patients with androgenetic alopecia were selected for the study. Patients who met the inclusion/exclusion criteria were randomly assigned to groups A and B in a 1:1 ratio to receive treatment, with the enrollment date designated as Day 1. Group A visited the clinic once each in the first, second, and third months for treatment with exosomes, while Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes. At the time points of 1, 2, 3, and 6 months after the start of the treatment period, dermatoscopic examinations were conducted on patients in both groups. The differences in hair growth density, hair shaft thickness, and follicle counts within a 1 cm diameter area were compared between the two groups. Additionally, the data differences for each subject at baseline and at the end of the experiment were also assessed.
- Conditions
- Androgenic Alopecia
- Being tested
- Human umbilical cord mesenchymal stem cells
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cellsDrug
Human umbilical cord mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A visited the clinic once each in the first, second, and third months for treatment with exosomes Receives: Drug: Human umbilical cord mesenchymal stem cells |
| Group B | Experimental | Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes. Receives: Drug: Human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
hair diameters changed over time
hair diameters changed over time
Measured: 0 days, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start28 Jun 2024
- Primary completion28 Sep 2024
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697080
- Sponsor's protocol ID
- NFEC-2024-323
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-controlled Clinical Trial to Treat Chinese Advanced AGA With Umbilical Cord-derived Mesenchymal Stem Cell Exosomes
- ClinicalTrials.gov ID
- NCT06697080
- Acronym / sponsor ID
- NFEC-2024-323
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 20 Nov 2024 (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.
A total of 50 patients with androgenetic alopecia were selected for the study. Patients who met the inclusion/exclusion criteria were randomly assigned to groups A and B in a 1:1 ratio to receive treatment, with the enrollment date designated as Day 1. Group A visited the clinic once each in the first, second, and third months for treatment with exosomes, while Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes. At the time points of 1, 2, 3, and 6 months after the start of the treatment period, dermatoscopic examinations were conducted on patients in both groups. The differences in hair growth density, hair shaft thickness, and follicle counts within a 1 cm diameter area were compared between the two groups. Additionally, the data differences for each subject at baseline and at the end of the experiment were also assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Human umbilical cord mesenchymal stem cellsGroup A visited the clinic once each in the first, second, and third months for treatment with exosomes |
| Group B | Experimental | Drug: Human umbilical cord mesenchymal stem cellsGroup B visited the clinic twice each in the first, second, and third months for treatment with exosomes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cellsHuman umbilical cord mesenchymal stem cells | Drug | Group A, Group B |
Primary outcome
hair diameters changed over time
Time frame: 0 days, 1 month, 3 months, 6 months
hair diameters changed over time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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 study testing Human umbilical cord mesenchymal stem cells in people with Androgenic Alopecia, run by Nanfang Hospital, Southern Medical University 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?
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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
hair diameters changed over time (time frame: 0 days, 1 month, 3 months, 6 months). 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 20 Nov 2024.