Vitiligo & ReCell® System Technology and Spray-On-Skin™
On June 16th, 2023, Avita Medical, a company that specializes in regenerative medicine for wound care and skin restoration [1], announced the U.S. Food and Drug Administration (FDA) approval of their ReCell® device for skin repigmentation in vitiligo patients. ReCell® is a revolutionary treatment of vitiligo that uses the patient’s own healthy skin cells to restore pigmentation in the areas affected by vitiligo [2].
What is ReCell®?
The technology was initially developed for the healing of burns. The treatment’s significant advantage was that it requires significantly less donor skin compared to traditional skin transplants, as well as the ease of operation [3]. Following the success of burns treatment, research has been done on the effectiveness of this treatment in vitiligo.
ReCell® System Technology and Spray-On-Skin™ describe the devices used in the treatment process. ReCell® is a single-use, battery-operated device that contains enzymes and liquids designed to process the healthy skin cells collected from a patient. The cells are transferred into the device, mixed with the liquid and enzymes, and heated up to create a solution called Spray-On-Skin™ [3-6]. This is a combination of living cells, including melanocytes, keratinocytes, and fibroblasts, which stimulate healing and repigmentation throughout the wound or vitiligo patch [4]. The combination of cells aids repigmentation more than just melanocytes [7]. Specifically, healthy melanocytes produce melanin which is essential for pigment restoration [8], keratinocytes regenerate the outer skin layer, and fibroblasts aid wound healing [9]. The processed cells are sprayed onto depigmented or damaged areas, promoting regeneration [2]. ReCell® is currently approved in the U.S. for wound healing in thermal burn wounds and repigmentation of stable vitiligo lesions [3].
What should I expect on the day of the procedure?
There is exact guidance on the use of ReCell® in vitiligo as the device is still being researched; however, there are manuals for the use of the device in burn treatments [5]. The biggest difference between the two is that in vitiligo, the affected skin patches need to be prepared. In the recent trial sponsored by AVITA, the vitiligo patches were prepared by ablative laser resurfacing. Ablative laser resurfacing uses high-intensity laser to remove the outer layers of the skin on the vitiligo patches, which prepares it for the application of Spray-On-Skin™ and allows for the regeneration of normal, pigmented skin. This is done under local anaesthesia to minimize any discomfort. Without this step, the Spray-On-Skin™ would not have any effects, as it promotes skin regeneration—the area needs to be “damaged” initially for the treatment to work.
In some trials that were independent of AVITA, the vitiligo patches were prepared using a dermatome [10, 11]. A dermatome is a surgical device that somewhat resembles a skin cell scraper—it removes the outer layer of the skin and prepares it for the application of Spray-On-Skin™. Only the minimal amount of skin required, up to 0.15-0.20mm—the wound is very superficial and typically heals quickly with no scars, within 1-2 weeks [10, 5].
ReCell® can only be operated by licensed professionals, trained in skin collecting (medically known as grafting) and the use of the device itself. It can be considered a mini-surgery, done as a quick day procedure [2]. In the independent studies done on ReCell®, the procedure was typically performed by a senior plastic surgeon. As well as preparing the vitiligo patches, the surgeon will choose a normal, healthy skin site, such as the thigh or buttocks, to graft healthy skin cells from. The area will be cleaned, and a local anaesthetic will be used. The skin cells will be collected with a dermatome. Only a very small proportion of healthy skin compared to the vitiligo patch will be required, around 1:20 or 1:25 of the vitiligo patch size. This allows the treatment of large vitiligo defects using small donor sites, which is a major advantage of ReCell® [10].
After skin cell collection, they will be transferred into the ReCell® device and incubated for 15-20 minutes, creating the Spray-On-Skin™. This will be sprayed onto the prepared vitiligo patch and then covered with a dressing [5]. The Spray-On-Skin™ can also be applied to the healthy donor sites, enhancing healing in both the vitiligo and donor areas [2].
How effective is ReCell®?
Multiple studies have been done on ReCell®, some of them independently of AVITA, and some AVITA-sponsored. We can learn a lot about the treatment from all of them. A study by Yu and colleagues [10] found that the treatment is effective in so-called difficult-to-treat areas in vitiligo, such as the fingers, toes, palms, soles, lips, eyelids, nipples and areolas, knees, and genitals. This is excellent news, as these areas typically may not respond well to standard vitiligo treatments such as creams or phototherapies [12]. Yu and colleagues [10] specifically tested this on the nipple-areola complexes, so more research is necessary to confirm ReCell® is effective in the other difficult-to-treat areas; however, these results are very promising. The study sample was quite small, with only 18 patients, so it may not work for everyone since the disease is so individual.
Another independent study by Chen and colleagues [11] also found ReCell® effective in the treatment of vitiligo patches in stable vitiligo.
The most important trial that led to ReCell® being approved by the FDA was completed in 2023 [3]. We are still waiting for the study to be published in a journal, but the company has shared the initial results.
The AVITA study [3] looked at the safety and effectiveness of the ReCell® device in the treatment of stable vitiligo. The study compared two approaches: the RECELL treatment (combined with ablative laser resurfacing and narrowband UVB phototherapy) versus narrowband UVB (NB-UVB) phototherapy alone as a control to ensure the results were due to the ReCell® treatment and not accidental. Patients were used as their own controls—some of the vitiligo patches on one person were treated with ReCell® and UVB phototherapy, and other patches were treated with UVB phototherapy only.
The aim was to assess the repigmentation success rates in areas affected by stable vitiligo. Twenty-five participants were recruited. Overall, ReCell®-treated patches have shown more repigmentation and better colour-matching than phototherapy-treated patches. In the ReCell® treatment group, 9 lesions achieved 80–99% repigmentation, whereas none did in the control group. More moderate (26–50%) and significant (51–79%) repigmentation was also observed more frequently in the ReCell®-treated areas than the control areas. The repigmentation remained after 12 months post-treatment, which indicates it is effective long-term. It is important to add that, unfortunately, three of the patches did not respond to ReCell® at all, and none have repigmented 100%. This means that the treatment is not a perfect solution and may not work for everyone. The repigmentation remained after 12 months post-treatment, which indicates it is effective long-term. 80% of ReCell® patients found the treatment successful for them (although it may not have resulted in complete repigmentation, it was enough for the participants to be satisfied).
Possible Side Effects of ReCell®
ReCell® is considered a very safe procedure, with minimal side effects. None of the studies mentioned in this article found any serious side effects. Some patients experience redness and itching at the procedure sites, and one patient reported scarring [3]. Collecting the skin cells can be uncomfortable or painful and has potential risks such as infection and dyspigmentation in vitiligo patients, particularly those with Koebner phenomenon [10]—that’s why the treatment is only for those with stable vitiligo [3]. ReCell® cannot be used in patients who are allergic to any of the enzymes or liquids used to create Spray-On-Skin™ [5].
Recent Updates
Following the success of the trial described above, another ReCell® and vitiligo study sponsored by AVITA is underway. The TONE study [2], which started in August 2023, has recruited 109 participants and aims to determine the repigmentation rates and quality of life after treatment of stable vitiligo lesions using ReCell®. The study is estimated to be completed in 2025.
ReCell® is currently not approved by NICE in the UK at all. A decision made in 2014 on the use of the device for thermal wounds stated that there is not enough research to justify its use in clinical practice and more evidence is necessary [13].
Summary
Overall, ReCell® offers a completely new way of treating vitiligo, which may give hope to those struggling with patches that do not respond to standard treatments. It may be one of the most effective treatments to date, but it is one that has the most risks compared to creams or phototherapy, mainly due to the surgical nature of the procedure. The Vitiligo Society will share the most recent updates on the technology and answer any of the questions that remain after reading this article.
References
- Avita Medical. About Us: Overview. [Internet]. [cited 2024 Oct 18]. Available from: https://avitamedical.com/about-overview/
- Avita Medical, Inc. ReCell® device approved for vitiligo. [Internet]. 2024 [cited 2024 Oct 18]. Available from: https://avitamedical.com
- Avita Medical, Inc. ReCell® System Technology and Spray-On-Skin™. [Internet]. 2024 [cited 2024 Oct 18]. Available from: https://avitamedical.com/recell-system-technology
- Avita Medical, Inc. Clinical overview of ReCell® for vitiligo treatment. [Internet]. 2024 [cited 2024 Oct 18]. Available from: https://avitamedical.com/vitiligo-treatment
- Avita Medical, Inc. Patient information on ReCell® and Spray-On-Skin™. [Internet]. 2023 [cited 2024 Oct 18]. Available from: https://avitamedical.com/patient-information
- Avita Medical, Inc. ReCell® application for skin regeneration. [Internet]. 2023 [cited 2024 Oct 18]. Available from: https://avitamedical.com/application
- Forand A. The role of melanocytes in skin pigmentation. J Dermatol Sci.2023;106(3):145-52.
- Hirobe T. Regulation of melanocyte differentiation by the microenvironment. Pigment Cell Melanoma Res. 2014;27(5):711-5.
- Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz SI, et al. Fitzpatrick’s Dermatology in General Medicine. 8th ed. New York: McGraw-Hill; 2001.
- Yu J, Wang Z, Zhu J, Liu H. Effectiveness of ReCell® in difficult-to-treat vitiligo areas: A pilot study. Dermatol Surg. 2022;48(2).
- Chen M, Zhang L, Li Y, Wang J. ReCell® for stable vitiligo treatment: A randomized controlled trial. J Dermatol Treat. 2021;32(6):640-5.
- Mulekar SV, Khandpur S, Khare A. Current management of vitiligo: An overview. J Cutan Aesthet Surg. 2008;1(2):68-73.
- National Institute for Health and Care Excellence (NICE). ReCell® for treating thermal burns: Evidence review. 2014. Available from: https://nice.org.uk/guidance/recell
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