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Autologous Non-cultured Epidermal Cell Suspension Transplantation in the Treatment of Vitiligo

ConditionVitiligo
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-65
SponsorPeking University People's Hospital

About this trial

To observe the long-term efficacy and safety of autologous non cultured epidermal cell suspension transplantation in the treatment of vitiligo, analyze the correlation between cell density, type, and postoperative efficacy and prognosis, and providing a basis for clinical application.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed as vitiligo, according to the "Vitiligo Diagnosis and Treatment Consensus (2021 edition)

Segmental and unclassified vitiligo stable for 6 months, Non-segmental vitiligo stable for 1 year and resistant to medication and phototherapy

BSA≥5%

Sign the informed consent and be willing to undergo surgical treatment

Disqualifiers

Severe visceral or infectious disease not suitable for surgical treatment

Tendency toward keloid formation

Coagulation defects

Unable to complete follow-up on time

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous Non-cultured Epidermal Cell Suspension transplantation

    Procedure/Surgery

    1. Thin split thickness skin grafts were taken from the donor site (anterolateral thigh) after application of topical anaesthesia under complete aseptic precautions. 2. The cell suspension was prepared by the cell sorting kit (Primcell, Jiangsu Repatec Life Science Co.,Ltd). 3. Then the recipient skin was uniformly dermabraded using an electrical dermabrader set at 10,000 to 20,000 rpm until punctate bleeding points appeared. 4. The cell suspension was applied onto the dermabraded recipient area. 5. The recipient site was then fixed firmly with dressings and elastic bandage. The dressings were removed 10 days after transplantation.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: NCESExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Repigmentation rate

The repigmentation rate depends on the percentage of repigmentation area /recipient area\*100%. The extent of repigmentation was devided as poor (less than 25%), good (26%-50%), very good (51%-75%), or excellent (more than75%).

Time frame
2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation

Secondary outcomes

1

Relative Melanin Index

The melanin index (MI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative MI (RMI) and were calculated as the ratio of the MI of the recipient sites relative to the symmetrical control skin region

Time frame
2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation
2

Relative erythema index

The erythema index (EI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative EI (REI) were calculated as the ratio of the EI of the recipient sites relative to the symmetrical control skin region

Time frame
2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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