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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.
1. Patient recruitment Inclusion criteria:
1) Severe visceral or infectious disease not suitable for surgical treatment 2) Tendency toward keloid formation 3) Coagulation defects 4) Unable to complete follow-up on time 2. Non-cultured epidermal cell suspension transplantation procedure
3. Postoperative Follow-Up All patients returned to the hospital for follow-up examinations at 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation.
The repigmentation was graded based on the percentage of the area of repigmentation as poor (less than 25%), good (26%-50%), very good (51%-75%), or excellent (more than 75%).
The melanin index (MI) and erythema index (EI) of the recipient sites were measured using a Mexameter MX18 (Courage 1Khazaka Electronic GmbH, Koln, Germany). The relative MI (RMI) and relative EI (REI) were calculated as the ratio of the MI or EI of the recipient sites relative to the symmetrical control skin region.
4. Laboratory Tests The cell number and vitality of the suspension was determined by an automatic intelligent cell counter. The flow cytometry was used to analyze the cell types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCES | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Non-cultured Epidermal Cell Suspension transplantation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 | 2 weeks, 1month, 2 months, 3 months, 4 months, 5 months and 6 months after transplantation |