Combined Therapy of Photoelectric Instruments and Human Umbilical Cord Mesenchymal Stem Cells for Pigmentary Disorders

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mesenchymal Stem Cells；Pigmentary Disorders
• Intervention / Treatment: Combination product: Mesenchymal Stem Cells；755nm picosecond laser treatment

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fuguo Zuo; Phone Number: 021-38804518; Email: 873106322@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must voluntarily participate in this study and sign a written informed consent form.
2. 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.
3. Subjects have never undergone stem cell therapy or laser treatment for melasma.

Exclusion Criteria:

1. Subjects with a history of photosensitivity or allergies to biological medications.
2. Subjects who are pregnant or lactating.
3. Subjects who have a history of alcohol abuse, drug addiction, or substance abuse in the past 24 months.
4. Subjects with concurrent severe systemic diseases, malignancies, or psychiatric disorders.
5. Subjects with active infections, including bacterial, fungal, and viral infections.
6. Subjects with keloid constitution.
7. Subjects with a history of severe sun exposure within 4 weeks before enrollment.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem Cell Treatment Group 1; Administer MSCs via intravenous infusion and multi-point injection into the melasma area, followed by combined treatment with 755nm picosecond laser.	Combination product: Mesenchymal Stem Cells；755nm picosecond laser treatment; 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.
Experimental: Stem Cell Treatment Group 2; Administer MSCs via multi-point injection into the melasma area, followed by combined treatment with 755nm picosecond laser.	Combination product: Mesenchymal Stem Cells；755nm picosecond laser treatment; 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.
Experimental: Control Group; Only administer 755nm picosecond laser treatment.	Combination product: Mesenchymal Stem Cells；755nm picosecond laser treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From 0 days to 2 years

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: ARSMO(Hainan) International Plastic & Aesthetic Hospital Company Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DFSC-2025(CR)-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No