Mesenchymal Stem Cells；Pigmentary DisordersPhase 1NCT06911281
Combined Therapy of Photoelectric Instruments and Human Umbilical Cord Mesenchymal Stem Cells for Pigmentary Disorders
A Phase 1 study testing Mesenchymal Stem Cells；755nm picosecond laser treatment in people with Mesenchymal Stem Cells；Pigmentary Disorders, run by Shanghai East Hospital.
Trial summary
Melasma is a common and refractory pigmentary skin disorder manifested as light to dark brown patches on the facial skin. It belongs to disfiguring dermatoses and significantly affects the physical and mental well-being of patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Mesenchymal Stem Cells；Pigmentary Disorders
- What is being tested?
- Mesenchymal Stem Cells；755nm picosecond laser treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 31 Dec 2027
- Phase
- Phase 1
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must voluntarily participate in this study and sign a written informed consent form.
- Subjects are female patients with melasma aged between 18 and 60 years. Their diagnosis should conform to the "Chinese Expert Consensus on Diagnosis and Treatment of Melasma (2021 Edition)" formulated by the Pigmentary Disorders Subgroup of the Dermatovenereology Committee of the China Association of Integrative Medicine. The skin lesions manifest as light brown or dark brown patches of varying depths and with indistinct borders on the cheeks, forehead, and jaw. Subjects must be excluded from having post-inflammatory hyperpigmentation, naevus of Ota, Riehl's melanosis, pigmented lichen planus, and other skin diseases. Additionally, their melasma should have been in a stable phase for 3 months or more.
- Subjects have never undergone stem cell therapy or laser treatment for melasma.
Who cannot join
- Subjects with a history of photosensitivity or allergies to biological medications.
- Subjects who are pregnant or lactating.
- Subjects who have a history of alcohol abuse, drug addiction, or substance abuse in the past 24 months.
- Subjects with concurrent severe systemic diseases, malignancies, or psychiatric disorders.
- Subjects with active infections, including bacterial, fungal, and viral infections.
- Subjects with keloid constitution.
- Subjects with a history of severe sun exposure within 4 weeks before enrollment.
- Subjects deemed unsuitable for enrollment by the investigator for various reasons or any other conditions that the investigator believes may compromise the safety or compliance of the subject or hinder the successful completion of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Combination Therapy of Photoelectric Instruments and Human Umbilical Cord Mesenchymal Stem Cells for Pigmentary Disorders
Melasma is a common and refractory pigmentary skin disorder manifested as light to dark brown patches on the facial skin. It belongs to disfiguring dermatoses and significantly affects the physical and mental well-being of patients. Conventional treatments for melasma, including pharmacological and photoelectric therapies, have high recurrence rates and suboptimal clinical efficacy. Preliminary evaluations of the therapeutic effects of human umbilical cord mesenchymal stem cells (MSCs) in melasma mouse models have shown that MSCs can significantly improve skin pigmentation, reduce malondialdehyde (MDA) levels indicating anti-aging effects, ameliorate skin inflammatory cell infiltration, and promote skin repair in these models. This study is a single-center, randomized controlled clinical trial aiming to build on previous experimental findings by combining MSCs with photoelectric therapy for the treatment of melasma. Patients will be divided into three groups of 10 each: Stem Cell Treatment Group 1, Stem Cell Treatment Group 2, and a Control Group. Group 1 will receive intravenous infusion of MSCs followed by multi-point injection into the melasma area in combination with 755nm picosecond laser treatment. Group 2 will receive multi-point injection of MSCs into the melasma area in combination with 755nm picosecond laser treatment. The Control Group will only receive 755nm picosecond laser treatment. Efficacy will be initially assessed based on parameters such as the Melasma Area and Severity Index (MASI), VISIA skin analysis, and patient satisfaction. The study aims to evaluate the efficacy and safety of MSCs combined with photoelectric therapy for melasma and to investigate the underlying mechanisms.
- Being tested
- Mesenchymal Stem Cells；755nm picosecond laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells；755nm picosecond laser treatmentCombination product
Stem Cell Treatment Group 1 received intravenous infusion of MSCs followed by multi-point injection into the melasma area, combined with 755nm picosecond laser treatment. Stem Cell Treatment Group 2 received multi-point injection of MSCs into the melasma area, combined with 755nm picosecond laser treatment. The Control Group only received 755nm picosecond laser treatment.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Treatment Group 1 | Experimental | Administer MSCs via intravenous infusion and multi-point injection into the melasma area, followed by combined treatment with 755nm picosecond laser. Receives: Combination Product: Mesenchymal Stem Cells；755nm picosecond laser treatment |
| Stem Cell Treatment Group 2 | Experimental | Administer MSCs via multi-point injection into the melasma area, followed by combined treatment with 755nm picosecond laser. Receives: Combination Product: Mesenchymal Stem Cells；755nm picosecond laser treatment |
| Control Group | Experimental | Only administer 755nm picosecond laser treatment. Receives: Combination Product: Mesenchymal Stem Cells；755nm picosecond laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation endpoint
The number of adverse events occurring throughout the entire study period. Analyze the frequency and occurrence of adverse events (including injection site reactions). Calculate adverse events, adverse reactions, and AE causing detachment separately SAE、 The number and frequency of AE with different degrees of severity and AE causing death.
Secondary endpoints: The primary evaluation includes the therapeutic effect of melasma and local discomfort.
Measured: From 0 days to 2 years
Pigmented Disease Area and Severity Index (MASI)
Quantitative analysis based on the area, depth, and uniformity of pigmentary diseases. Assess pigmentation areas in four regions: forehead (F) 30%, right cheek (MR) 30%, left cheek (ML) 30%, and mandible (C) 10%. According to the proportion of pigmentation spots in the four regions, the scores are: 1 is less than 10%, 2 is 10% -29%, 3 is 30% -49%, 4 is 50% -69%, 5 is 70% -89%, and 6 is 90% -100%. Color depth (D) and uniformity (H) scores: 0-4 points: none 0 points, slight 1 point, moderate 2 points, obvious 3 points, highest 4 points. MASI=forehead [0.3A (D+H)]+right cheek [0.3A (D+H)]+left cheek [0.3A (D+H)]+mandible [0.1A (D+H)]. The highest score is 48 points, and the lowest score is 0 points.
Measured: From 0 days to 2 years
VISIA Image Analysis System
VISIA image analysis system: uses different light sources such as standard, ultraviolet, and orthogonal polarization to quantify different skin states. Patients with pigmentary diseases can determine the quantity, distribution, area, depth, and capillary condition of pigments through surface, ultraviolet, and brown spots.
Measured: From 0 days to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stem Cells；Pigmentary DisordersStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ARSMO(Hainan) International Plastic & Aesthetic Hospital Company Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911281
- Sponsor's protocol ID
- DFSC-2025(CR)-01
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Combination Therapy of Photoelectric Instruments and Human Umbilical Cord Mesenchymal Stem Cells for Pigmentary Disorders
- ClinicalTrials.gov ID
- NCT06911281
- Acronym / sponsor ID
- DFSC-2025(CR)-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- ARSMO(Hainan) International Plastic & Aesthetic Hospital Company Limited
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 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.
Melasma is a common and refractory pigmentary skin disorder manifested as light to dark brown patches on the facial skin. It belongs to disfiguring dermatoses and significantly affects the physical and mental well-being of patients. Conventional treatments for melasma, including pharmacological and photoelectric therapies, have high recurrence rates and suboptimal clinical efficacy. Preliminary evaluations of the therapeutic effects of human umbilical cord mesenchymal stem cells (MSCs) in melasma mouse models have shown that MSCs can significantly improve skin pigmentation, reduce malondialdehyde (MDA) levels indicating anti-aging effects, ameliorate skin inflammatory cell infiltration, and promote skin repair in these models. This study is a single-center, randomized controlled clinical trial aiming to build on previous experimental findings by combining MSCs with photoelectric therapy for the treatment of melasma. Patients will be divided into three groups of 10 each: Stem Cell Treatment Group 1, Stem Cell Treatment Group 2, and a Control Group. Group 1 will receive intravenous infusion of MSCs followed by multi-point injection into the melasma area in combination with 755nm picosecond laser treatment. Group 2 will receive multi-point injection of MSCs into the melasma area in combination with 755nm picosecond laser treatment. The Control Group will only receive 755nm picosecond laser treatment. Efficacy will be initially assessed based on parameters such as the Melasma Area and Severity Index (MASI), VISIA skin analysis, and patient satisfaction. The study aims to evaluate the efficacy and safety of MSCs combined with photoelectric therapy for melasma and to investigate the underlying mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Treatment Group 1 | Experimental | Combination Product: Mesenchymal Stem Cells；755nm picosecond laser treatmentAdminister MSCs via intravenous infusion and multi-point injection into the melasma area, followed by combined treatment with 755nm picosecond laser. |
| Stem Cell Treatment Group 2 | Experimental | Combination Product: Mesenchymal Stem Cells；755nm picosecond laser treatmentAdminister MSCs via multi-point injection into the melasma area, followed by combined treatment with 755nm picosecond laser. |
| Control Group | Experimental | Combination Product: Mesenchymal Stem Cells；755nm picosecond laser treatmentOnly administer 755nm picosecond laser treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must voluntarily participate in this study and sign a written informed consent form.
- Subjects are female patients with melasma aged between 18 and 60 years. Their diagnosis should conform to the "Chinese Expert Consensus on Diagnosis and Treatment of Melasma (2021 Edition)" formulated by the Pigmentary Disorders Subgroup of the Dermatovenereology Committee of the China Association of Integrative Medicine. The skin lesions manifest as light brown or dark brown patches of varying depths and with indistinct borders on the cheeks, forehead, and jaw. Subjects must be excluded from having post-inflammatory hyperpigmentation, naevus of Ota, Riehl's melanosis, pigmented lichen planus, and other skin diseases. Additionally, their melasma should have been in a stable phase for 3 months or more.
- Subjects have never undergone stem cell therapy or laser treatment for melasma.
Key exclusion criteria (8 listed)
- Subjects with a history of photosensitivity or allergies to biological medications.
- Subjects who are pregnant or lactating.
- Subjects who have a history of alcohol abuse, drug addiction, or substance abuse in the past 24 months.
- Subjects with concurrent severe systemic diseases, malignancies, or psychiatric disorders.
- Subjects with active infections, including bacterial, fungal, and viral infections.
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 |
|---|---|---|
| Mesenchymal Stem Cells；755nm picosecond laser treatmentStem Cell Treatment Group 1 received intravenous infusion of MSCs followed by multi-point injection into the melasma area, combined with 755nm picosecond laser treatment. Stem Cell Treatment Group 2 received multi-point injection of MSCs into the melasma area, combined with 755nm picosecond laser treatment. The Control Group only received 755nm picosecond laser treatment. | Combination product | Control Group, Stem Cell Treatment Group 1, Stem Cell Treatment Group 2 |
Primary outcome
Safety evaluation endpoint
Time frame: From 0 days to 2 years
The number of adverse events occurring throughout the entire study period. Analyze the frequency and occurrence of adverse events (including injection site reactions). Calculate adverse events, adverse reactions, and AE causing detachment separately SAE、 The number and frequency of AE with different degrees of severity and AE causing death. Secondary endpoints: The primary evaluation includes the therapeutic effect of melasma and local discomfort.
Pigmented Disease Area and Severity Index (MASI)
Time frame: From 0 days to 2 years
Quantitative analysis based on the area, depth, and uniformity of pigmentary diseases. Assess pigmentation areas in four regions: forehead (F) 30%, right cheek (MR) 30%, left cheek (ML) 30%, and mandible (C) 10%. According to the proportion of pigmentation spots in the four regions, the scores are: 1 is less than 10%, 2 is 10% -29%, 3 is 30% -49%, 4 is 50% -69%, 5 is 70% -89%, and 6 is 90% -100%. Color depth (D) and uniformity (H) scores: 0-4 points: none 0 points, slight 1 point, moderate 2 points, obvious 3 points, highest 4 points. MASI=forehead [0.3A (D+H)]+right cheek [0.3A (D+H)]+left cheek [0.3A (D+H)]+mandible [0.1A (D+H)]. The highest score is 48 points, and the lowest score is 0 points.
VISIA Image Analysis System
Time frame: From 0 days to 2 years
VISIA image analysis system: uses different light sources such as standard, ultraviolet, and orthogonal polarization to quantify different skin states. Patients with pigmentary diseases can determine the quantity, distribution, area, depth, and capillary condition of pigments through surface, ultraviolet, and brown spots.
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 4 Apr 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cells；755nm picosecond laser treatment in people with Mesenchymal Stem Cells；Pigmentary Disorders, run by Shanghai East Hospital.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Fuguo Zuo (021-38804518, 873106322@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation endpoint (time frame: From 0 days to 2 years). 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 4 Apr 2025.