Pipeline: Vitiligo

EXPLORING POTENTIAL APPLICATION IN VITILIGO

Vitiligo is a disease affecting approximately 6.5 million people in the U.S. resulting in loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition. [1], [2]

Ongoing research with the RECELL® System for the treatment of skin defects, such as vitiligo and dermatological diseases, helps share experiences among the medical community. Below is a case study provided as background. For general information about our science and technology, please contact our Medical Affairs team.

Click here for more information about eligibility and enrollment in AVITA Medical’s Vitiligo Clinical Study.

CASE STUDY: STABLE VITILIGO

Researchers conducted a randomized controlled pilot study utilizing Spray-On Skin™ Cells for the treatment of stable vitiligo and piebaldism patients. The image below shows two recipients sites before and 6 months after treatment[3].

Vitiligo Fact Sheet

Size: 610KB
Type: PDF

RECELL treated vitiligo patient

AT 6 MONTHS
RECELL®-TREATED AREA WAS 100% REPIGMENTED


RECELL® System Mechanism of Action for Stable Vitiligo: Animated Video

Clinical studies are underway exploring the use of RECELL® for the repigmentation of stable vitiligo. This animated video illustrates how the RECELL® System may work to restore pigmentation to a vitiligo patch following use of a laser to prepare the skin.

ADDITIONAL RESEARCH: Abstracts, Posters, Presentations

  • Uitentuis et al. Clin Exp Dermatol. Impact of graft cell density and viability on repigmentation upon noncultured autologous cell suspension transplantation in vitiligo and piebaldism. 2020 Oct;45(7):907-908.
    https://pubmed.ncbi.nlm.nih.gov/32311146
  • Chen et al. Dermatol Surg. 2020 Oct 2. New Pigmentation after Medical Treatment Suggests Increased Efficacy of Dermabrasion and Non-cultured Epidermal Cell Suspension Techniques in Stable Vitiligo.
    https://pubmed.ncbi.nlm.nih.gov/33038103
  • PRESENTATION. Uitentuis. Autologous cell suspension transplantation concurrent with UVB in non-segmental vitiligo patients: a randomized controlled study. 2020 July 18-20; IPCC Japan; Yamagata, Japan.
  • PRESENTATION. L Fei. Repigmentation with RECELL® technology and dermabrasion in stable Vitiligo. 2019 September 9; National Academic Exchange Conference of the Chinese Medical Association Plastic Surgery Branch of the Chinese Academy of Medical Sciences and Plastic Surgery; Beijing, China.
  • PRESENTATION. L Zhifei. Repigmentation with RECELL® technology and dermabrasion in stable Vitiligo. 2019 September 9; 8th Chinese Annual Meeting, Minimally Invasive Aesthetic Medicine; China.
  • Ren et al. J Cosmet Deratol. The use of noncultured regenerative epithelial suspension for improving skin color and scars: A report of 8 cases and review of the literature. 2019 Jul 26.
    https://onlinelibrary.wiley.com/doi/abs/10.1111/jocd.13071
  • POSTER: L Wei Wei. Is suction blister epidermal grafting a simple and reliable way to screen patients with large area vitiligo for RECELL® treatment? 2019 June 10-15; World Congress of Dermatology; Milan, Italy.
  • POSTER: L Zhifei. Spontaneous pigmentation spots are signs of successful RECELL® therapy in patients with stable large area vitiligo. 2019 June 10-15; World Congress of Dermatology; Milan, Italy.
  • POSTER: Y Nu. Is suction blister epidermal grafting a simple and reliable way to screen patients with large area vitiligo for RECELL® treatment? 2019 June 10-15; World Congress of Dermatology; Milan, Italy.
  • Liu et al. J Dermatolog Treat. The clinical efficacy of treatment using the autologous non-cultured epidermal cell suspension technique for stable vitiligo in 41 patients. 2019 May 31:1-5.
    https://pubmed.ncbi.nlm.nih.gov/31084382/
  • Lommerts et. al. BJ Dermatol. Autologous cell suspension grafting in segmental vitiligo and piebaldism: a randomized controlled trial comparing full surface and fractional CO2 laser recipient-site preparations. 2017;177:1293-1298.
    https://pubmed.ncbi.nlm.nih.gov/28403523/
  • POSTER: S Uitentuis. Impact of graft cell density and viability on repigmentation upon non-cultured autologous cell suspension transplantation in vitiligo. International Pigment Cell Conference (IPCC). 2017.
  • POSTER: Z Liu. Is suction blister epidermal grafting a simple and reliable way to screen patients with large area vitiligo for RECELL® treatment? European Society for Dermatological Research. 2017.
  • PRESENTATION: W Li. A new method to improve the efficacy of RECELL® technology in patients with stable vitiligo — Foaming. Plastic Surgery. 2017.
  • Komen et al. J Cutan Aesthet Surg. Observations on CO2 laser preparation of recipient site for noncultured cell suspension transplantation in vitiligo. 2016 Apr-Jun;9(2):133-5. doi: 10.4103/0974-2077.184055
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4924413/
  • Komen et. al. J Am Acad Dermatol. Autologous cell suspension transplantation using a cell extraction device in segmental vitiligo and piebaldism patients: A randomized controlled pilot study. 2015 Jul;73(1):170-2
    https://pubmed.ncbi.nlm.nih.gov/26089056/
  • POSTER: Wolkerstorfer. Vitiligo-Piebaldism. American Society for Laser Medicine and Surgery (ASLMS). 2014.
  • POSTER: Komen. Autologous cell suspension transplantation using a cell harvesting device in segmental vitiligo and piebaldism patients: a randomized controlled pilot study. International Pigment Cell Conference (IPCC). 2014.
  • Cervelli et al. European Review for Medical and Pharmacological Sciences. Treatment of stable vitiligo hands by RECELL® system: a preliminary report. 2010;14(8):691-4
    https://pubmed.ncbi.nlm.nih.gov/20707289/
  • Cervelli et al. Acta Dernatovenerol Croat. Treatment of stable vitiligo by RECELL® System. 2009;17(4):273-278.
    https://pubmed.ncbi.nlm.nih.gov/20021980/
  • Mulekar et. al. Br J Dermatol. Treatment of vitiligo lesions by RECELL® vs conventional melanocyte keratinocyte transplantation: a pilot study. 2008 Jan;158(1):45-9
    https://pubmed.ncbi.nlm.nih.gov/17927795/

CAUTION:  The use of RECELL® as a treatment of stable vitiligo lesions is limited by U.S. law to investigational use.

The RECELL® System is approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute thermal burns in patients 18 years and older. Click here for Important Safety Information and Instructions for Use.

  1. Advances in Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon, et al. J Clin Aesth Derm. 2017
  2. Willingness-to-pay and quality of life in patients with vitiligo. Radtke, et al. BJD. 2009
  3. Autologous cell suspension transplantation using a cell extraction device in segmental vitiligo and piebaldism patients: A randomized controlled pilot study. Koman, et al. JAAD 2015

IMPORTANT SAFETY INFORMATION (United States)

INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients.

CONTRAINDICATIONS: RECELL® is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

WARNINGS AND PRECAUTIONS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed.

PRECAUTIONS: RECELL® is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL® without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, and in patients younger than 28 days of age (neonates).

SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL® have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age.

For complete Important Safety Information, refer to Instructions For Use. Please be aware that any indication for RECELL® outside of the United States may differ from the US indication. Please see the Instructions for Use for each country for the specific indication of RECELL®.

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©Copyright 2022 AVITA Medical. All Rights Reserved.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to AVITA, its subsidiaries or affiliates. No use of any AVITA trademark, trade name, or trade dress in this site may be made without the prior written authorization of AVITA, except to identify the product or services of the company.
©Copyright 2022 AVITA Medical. All Rights Reserved.