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<p>Regenerative medicine is supported by a growing body of evidence for cutaneous disease, yet dermatologists lack a specialty-focused synthesis that benchmarks regenerative interventions against contemporary standards of care (SoC) and clarifies where higher-quality clinical evidence currently exists. Herein, we performed a literature search (2013–2025) to map human clinical studies of regenerative interventions in dermatology; in sum, 175 full-text articles/abstracts were screened and 84 eligible clinical studies were extracted (Supplementary Table S1). Each study was assigned an Oxford Centre for Evidence-Based Medicine (OCEBM) level of evidence for treatment benefits based on study design. Among 84 studies, evidence clustered in Level 4 (41/84) and Level 2 (33/84), with fewer Level 3 (8/84) and Level 1 syntheses (2/84). Benchmarking to an active SoC comparator was uncommon (15/84), while nearly 50% of studies were single-arm without a comparator (41/84) and 13/84 used placebo/vehicle/sham controls. Higher-level evidence was concentrated in a limited subset of indications and modalities with measurable endpoints and more standardized workflows, including topical COL7A1 gene therapy for dystrophic epidermolysis bullosa (beremagene geperpavec); autologous skin cell suspension transplantation for stable vitiligo; platelet-rich plasma protocols for androgenetic alopecia; and immune-reset strategies, such as autologous hematopoietic stem-cell transplantation, for severe systemic sclerosis in specialized centers. Overall, the medical dermatology evidence base remains early-stage with heterogeneity in regenerative biotherapies, protocols, endpoints, and follow-up. There is a paucity of head-to-head trials versus optimized SoC; yet, literature demonstrates clinically meaningful signals in select conditions. With continued rigor in manufacturing standardization, quality control, validated outcome measures, long-term safety and comparative trial design, regenerative platforms warrant cautious optimism for expanding therapeutic options in dermatologic disease.</p>

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Emerging concepts: regenerative medicine in dermatology

  • 期刊论文

  • 发表日期：

    2026年6月25日

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  • Brock M. Lynn,
  • Samantha M. Guhan,
  • Kavita Mariwalla,
  • Patricia Farris,
  • Murad Alam,
  • Saranya P. Wyles

摘要

Regenerative medicine is supported by a growing body of evidence for cutaneous disease, yet dermatologists lack a specialty-focused synthesis that benchmarks regenerative interventions against contemporary standards of care (SoC) and clarifies where higher-quality clinical evidence currently exists. Herein, we performed a literature search (2013–2025) to map human clinical studies of regenerative interventions in dermatology; in sum, 175 full-text articles/abstracts were screened and 84 eligible clinical studies were extracted (Supplementary Table S1). Each study was assigned an Oxford Centre for Evidence-Based Medicine (OCEBM) level of evidence for treatment benefits based on study design. Among 84 studies, evidence clustered in Level 4 (41/84) and Level 2 (33/84), with fewer Level 3 (8/84) and Level 1 syntheses (2/84). Benchmarking to an active SoC comparator was uncommon (15/84), while nearly 50% of studies were single-arm without a comparator (41/84) and 13/84 used placebo/vehicle/sham controls. Higher-level evidence was concentrated in a limited subset of indications and modalities with measurable endpoints and more standardized workflows, including topical COL7A1 gene therapy for dystrophic epidermolysis bullosa (beremagene geperpavec); autologous skin cell suspension transplantation for stable vitiligo; platelet-rich plasma protocols for androgenetic alopecia; and immune-reset strategies, such as autologous hematopoietic stem-cell transplantation, for severe systemic sclerosis in specialized centers. Overall, the medical dermatology evidence base remains early-stage with heterogeneity in regenerative biotherapies, protocols, endpoints, and follow-up. There is a paucity of head-to-head trials versus optimized SoC; yet, literature demonstrates clinically meaningful signals in select conditions. With continued rigor in manufacturing standardization, quality control, validated outcome measures, long-term safety and comparative trial design, regenerative platforms warrant cautious optimism for expanding therapeutic options in dermatologic disease.