Hair TransplantationNCT05659095
Autologous Hair Follicle Derived Mesenchymal Stem Cell Suspension to Treat AGA
A study testing autologous hair follicle derived mesenchymal stem cell suspension in people with Hair Transplantation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Androgenic alopecia (AGA) is characterized by progressive hair follicle miniaturization, and novel treatments are needed to intervene in the miniaturization process. The investigators aimed to evaluate the efficacy, safety, effectiveness, and effective population of autologous hair follicle mesenchymal stem cell… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Transplantation
- What is being tested?
- autologous hair follicle derived mesenchymal stem cell suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of Androgenic alopecia
- AGA classification include：The Norwood grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III
Who cannot join
- (1) Using medications or supplements, including finasteride, dutasteride, ketoconazole, minoxidil or any other hormonal products, that can affect hair growth;
- (2) Patients with severe systemic diseases, immune diseases, endocrine diseases and nervous system diseases;
- (3) Patients with head skin 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, 510000
About this study
Official title: A Randomized-controlled Clinical Trial to Treat Chinese Advanced AGA With Autologous Hair Follicle Derived Mesenchymal Stem Cell Suspension
Androgenic alopecia (AGA) is characterized by progressive hair follicle miniaturization, and novel treatments are needed to intervene in the miniaturization process. The investigators aimed to evaluate the efficacy, safety, effectiveness, and effective population of autologous hair follicle mesenchymal stem cell therapy for the treatment of advanced AGA in Chinese people.
50 participants ranging from 25 to 45 years old, with an average age of 32 ± 1.24 years were included. None of them had ever used minoxidil, finasteride, or other drugs to promote hair growth. Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months. Observers were blinded to patient groupings and measurements.
Read the detailed description
Androgenic alopecia (AGA) is the most common form of hair loss. It starts in adolescence and is mainly characterized by progressive hair follicle miniaturization. In the continuous hair cycle process, the pathological hair follicle mesenchymal niche in the hair loss area is continuously damaged. The mesenchymal cells are continuously consumed, resulting in functional disorder, gradually losing the ability to induce the proliferation and differentiation of hair follicle epidermal cells to form hair follicles. This process eventually leads to the complete miniaturization and loss of hair follicles. Presently, non-surgical treatments for AGA, such as minoxidil or finasteride, have great individual differences in the effectiveness in different populations and may not achieve the expected effect of patients with advanced AGA, although they are still recommended as first-line drugs for androgenic alopecia.
Hair follicle mesenchymal stem cells (HF-MSCs) included dermal papilla cells (DPCs) and dermal sheath cells (DSCs). Similar to other types of mesenchymal stem cells, HF-MSCs possess stem cell characteristics such as multidirectional differentiation potential, the ability of integrated homing to a specific niche, and secretion of exosomes and cytokines, which have great application prospects. HF-MSCs are considered an important therapeutic agent to promote hair growth. A previous study has indicated that injection of DPC spheres can promote hair growth on the back of mice. A double-blind clinical trial in Japan confirmed that treatment of the expanded dermal sheath cup cells (DSCCs) of healthy human hair follicles could promote the growth of hair follicles in the hair loss area of the forehead. However, the population and stage of AGA for which HF-MSC therapy is effective have not yet been reported. The investigators conducted a randomized clinical trial, extracted hair follicles from the human occipital area, prepared an HF-MSC suspension and locally injected it into the forehead hair loss area. Through follow-up observations, this study aimed to evaluate the safety and effectiveness of autologous hair follicle mesenchymal stem cell therapy in the treatment of AGA. The investigators expounded the possible effective population and stage.
- Conditions
- Hair Transplantation
- Being tested
- autologous hair follicle derived mesenchymal stem cell suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous hair follicle derived mesenchymal stem cell suspensionOther
Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Experiment groups | Experimental | Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. Receives: Other: autologous hair follicle derived mesenchymal stem cell suspension |
| Control groups | No intervention | The control group was injected with the same volume of normal saline. |
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, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair TransplantationStudies 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
- Investigators
- Zhiqi Hu, phD, Study chair, southern hosptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659095
- Sponsor's protocol ID
- NFEC-2020-245
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. 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 Autologous Hair Follicle Derived Mesenchymal Stem Cell Suspension
- ClinicalTrials.gov ID
- NCT05659095
- Acronym / sponsor ID
- NFEC-2020-245
- Conditions
- Hair Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 21 Dec 2022 (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.
Androgenic alopecia (AGA) is characterized by progressive hair follicle miniaturization, and novel treatments are needed to intervene in the miniaturization process. The investigators aimed to evaluate the efficacy, safety, effectiveness, and effective population of autologous hair follicle mesenchymal stem cell therapy for the treatment of advanced AGA in Chinese people.
50 participants ranging from 25 to 45 years old, with an average age of 32 ± 1.24 years were included. None of them had ever used minoxidil, finasteride, or other drugs to promote hair growth. Healthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months. Observers were blinded to patient groupings and measurements.
Detailed description
Androgenic alopecia (AGA) is the most common form of hair loss. It starts in adolescence and is mainly characterized by progressive hair follicle miniaturization. In the continuous hair cycle process, the pathological hair follicle mesenchymal niche in the hair loss area is continuously damaged. The mesenchymal cells are continuously consumed, resulting in functional disorder, gradually losing the ability to induce the proliferation and differentiation of hair follicle epidermal cells to form hair follicles. This process eventually leads to the complete miniaturization and loss of hair follicles. Presently, non-surgical treatments for AGA, such as minoxidil or finasteride, have great individual differences in the effectiveness in different populations and may not achieve the expected effect of patients with advanced AGA, although they are still recommended as first-line drugs for androgenic alopecia.
Hair follicle mesenchymal stem cells (HF-MSCs) included dermal papilla cells (DPCs) and dermal sheath cells (DSCs). Similar to other types of mesenchymal stem cells, HF-MSCs possess stem cell characteristics such as multidirectional differentiation potential, the ability of integrated homing to a specific niche, and secretion of exosomes and cytokines, which have great application prospects. HF-MSCs are considered an important therapeutic agent to promote hair growth. A previous study has indicated that injection of DPC spheres can promote hair growth on the back of mice. A double-blind clinical trial in Japan confirmed that treatment of the expanded dermal sheath cup cells (DSCCs) of healthy human hair follicles could promote the growth of hair follicles in the hair loss area of the forehead. However, the population and stage of AGA for which HF-MSC therapy is effective have not yet been reported. The investigators conducted a randomized clinical trial, extracted hair follicles from the human occipital area, prepared an HF-MSC suspension and locally injected it into the forehead hair loss area. Through follow-up observations, this study aimed to evaluate the safety and effectiveness of autologous hair follicle mesenchymal stem cell therapy in the treatment of AGA. The investigators expounded the possible effective population and stage.
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 |
|---|---|---|
| Experiment groups | Experimental | Other: autologous hair follicle derived mesenchymal stem cell suspensionHealthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. |
| Control groups | No intervention | –The control group was injected with the same volume of normal saline. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Androgenic alopecia
- AGA classification include：The Norwood grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III
Key exclusion criteria (3 listed)
- (1) Using medications or supplements, including finasteride, dutasteride, ketoconazole, minoxidil or any other hormonal products, that can affect hair growth;
- (2) Patients with severe systemic diseases, immune diseases, endocrine diseases and nervous system diseases;
- (3) Patients with head skin infection, allergic disease and malignant tumor
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 |
|---|---|---|
| autologous hair follicle derived mesenchymal stem cell suspensionHealthy hair follicles were extracted from the occipital area and treated to obtain hair follicle mesenchymal stem cells suspensions. The recipient sites were divided into two groups. Nine points were injected in a 1 cm2 area, and 100 μl of solution containing either 1 × 105 cells or normal saline was injected at each point. The follow-up duration was 9 months. | Other | Experiment groups |
Primary outcome
hair diameters changed over time
Time frame: 0 days, 1 month, 3 months, 6 months, and 9 months
hair diameters changed over time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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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.
Zhiqi Hu, phD study chair
southern hosptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous hair follicle derived mesenchymal stem cell suspension in people with Hair Transplantation, 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?
The sponsor lists 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, and 9 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 21 Dec 2022.