Iltefat H Hamzavi, Anand K Ganesan, Bassel H Mahmoud, Eduardo Weiss, Ammar M Ahmed, Deanne Robinson, Mitchel P Goldman, Girish Munavalli, Steven A Kahn, Victor Huang, Jill Waibel, Alpesh Desai, Nada Elbuluk, Seemal Desai, Amit G Pandya
{"title":"有效、持久的稳定期白癜风再色素沉着:一项评估自体皮肤细胞悬浮移植疗法的随机受试者内对照试验。","authors":"Iltefat H Hamzavi, Anand K Ganesan, Bassel H Mahmoud, Eduardo Weiss, Ammar M Ahmed, Deanne Robinson, Mitchel P Goldman, Girish Munavalli, Steven A Kahn, Victor Huang, Jill Waibel, Alpesh Desai, Nada Elbuluk, Seemal Desai, Amit G Pandya","doi":"10.1016/j.jaad.2024.08.027","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation.</p><p><strong>Objective: </strong>To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults.</p><p><strong>Methods: </strong>A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52.</p><p><strong>Results: </strong>Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes.</p><p><strong>Limitations: </strong>Study sample size limited robust subgroup analyses.</p><p><strong>Conclusion: </strong>Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease.</p>","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":null,"pages":null},"PeriodicalIF":12.8000,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effective and durable repigmentation for stable vitiligo: A randomized within-subject controlled trial assessing treatment with autologous skin cell suspension transplantation.\",\"authors\":\"Iltefat H Hamzavi, Anand K Ganesan, Bassel H Mahmoud, Eduardo Weiss, Ammar M Ahmed, Deanne Robinson, Mitchel P Goldman, Girish Munavalli, Steven A Kahn, Victor Huang, Jill Waibel, Alpesh Desai, Nada Elbuluk, Seemal Desai, Amit G Pandya\",\"doi\":\"10.1016/j.jaad.2024.08.027\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation.</p><p><strong>Objective: </strong>To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults.</p><p><strong>Methods: </strong>A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52.</p><p><strong>Results: </strong>Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes.</p><p><strong>Limitations: </strong>Study sample size limited robust subgroup analyses.</p><p><strong>Conclusion: </strong>Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease.</p>\",\"PeriodicalId\":17198,\"journal\":{\"name\":\"Journal of the American Academy of Dermatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":12.8000,\"publicationDate\":\"2024-09-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American Academy of Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jaad.2024.08.027\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Academy of Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaad.2024.08.027","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Effective and durable repigmentation for stable vitiligo: A randomized within-subject controlled trial assessing treatment with autologous skin cell suspension transplantation.
Background: Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation.
Objective: To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults.
Methods: A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52.
Results: Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes.
Limitations: Study sample size limited robust subgroup analyses.
Conclusion: Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease.
期刊介绍:
The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.