What is RECELL, and what does the procedure include?
RECELL is a single-use device that processes a small sample of a person’s pigmented skin into a mixed suspension containing melanocytes and other skin cells. A trained professional applies it to a vitiligo area prepared with an ablative laser. It is not cultured stem-cell therapy, gene therapy, or a stand-alone “cell spray” cure. Evidence Evidence Evidence
Why this matters
The device processes a patient’s own pigmented donor skin at the point of care. The FDA-defined vitiligo procedure includes trained professional use, a donor sample, cell processing, laser-prepared recipient skin, dressings, and follow-up.
Questions for an experienced procedural specialist
- Which exact RECELL model and instructions will be used?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- Which parts of the procedure happen at the donor site and recipient site?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- What training does this center have for vitiligo?Saving keeps this on your device and needs JavaScript, which is off in this browser.
Where is RECELL authorized for vitiligo?
The FDA PMA-approved RECELL for repigmentation of stable depigmented vitiligo lesions in adults under defined professional-use conditions. SteadySkin could not verify a current model-specific EU or UK vitiligo scope from a regulator-hosted certificate and instructions. So the US indication must not be transferred to those jurisdictions. Evidence Evidence
Why this matters
The FDA record is model- and indication-specific. A CE mark, device registration, company announcement, or use for wounds does not by itself prove a current vitiligo scope for another model or jurisdiction.
Questions for an experienced procedural specialist
- Is this exact model authorized for vitiligo here?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- Can the center show the current indication and instructions?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- Which regulator or conformity body record supports that claim?Saving keeps this on your device and needs JavaScript, which is off in this browser.
Who was studied, and what were the absolute results?
At week 24, 9 of 25 RECELL areas reached at least 80% repigmentation versus 0 of 25 matched controls. That was the pivotal within-person randomized study of 25 adults with stable focal, segmental, or generalized vitiligo. Fourteen of 25 RECELL areas, or 56%, reached more than 50% repigmentation versus 3 of 25 controls, or 12%. No studied area reached complete repigmentation. Evidence
Why this matters
Each participant contributed matched areas, which reduces some person-to-person differences. At week 24, 9 of 25 RECELL areas versus 0 of 25 controls reached at least 80% repigmentation; 14 of 25 versus 3 of 25 reached more than 50%. Studied areas included head, neck, dorsal hands, dorsal feet, arms, legs, trunk, and other areas.
Questions for an experienced procedural specialist
- Do my patches and body sites resemble those studied?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- What did the study define as a meaningful result?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- How should I interpret a partial or patchy result?Saving keeps this on your device and needs JavaScript, which is off in this browser.
What risks and exclusions belong to the full procedure?
RECELL is contraindicated for known hypersensitivity to trypsin or compound sodium lactate, also called Hartmann’s solution. The instructions also say skin-sample collection should not be used when there is known hypersensitivity to anesthetics, adrenaline or epinephrine, povidone-iodine, or chlorhexidine. The procedure adds a donor wound, ablative-laser resurfacing, anesthesia, dressings, and wound aftercare. Reported or labeled concerns include scarring, hypertrophic scarring, redness, itching, infection, Koebner phenomenon, worsening vitiligo, and limits for several body sites and populations. The Koebner phenomenon is the name for patches that develop where previously unaffected skin was injured. A procedure injures skin on purpose, at the donor site and at the treated one. Evidence Evidence Evidence
Why this matters
The instructions contraindicate RECELL for known hypersensitivity to trypsin or compound sodium lactate, also called Hartmann’s solution. They also say skin-sample collection should not be used with known hypersensitivity to anesthetics, adrenaline or epinephrine, povidone-iodine, or chlorhexidine. The pivotal record reported seven treatment-emergent events in five people, including scar, redness, itching, donor-site hypertrophic scar, and Koebner phenomenon.
Questions for an experienced procedural specialist
- What are my donor-site, laser, scar, infection, and Koebner risks?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- Which of my body sites are outside the established evidence?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- What happens if healing or pigment return misses the goal?Saving keeps this on your device and needs JavaScript, which is off in this browser.
What center, recovery, and coverage burden should I expect?
RECELL requires a trained procedural center, suitable stable patches and donor skin, laser capability, wound care, follow-up, and coordination of the complete package. Coverage and personal cost are center- and payer-specific; SteadySkin found no authoritative national price that can stand in for a written estimate. Evidence Evidence
Why this matters
A useful written estimate should distinguish the device, clinician, facility, donor-site care, laser, dressings, follow-up, phototherapy, travel, and time away from normal responsibilities. A center’s quote is not proof of coverage.
Questions for an experienced procedural specialist
- How many vitiligo procedures has this team performed with this model?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- What does the written quote include and exclude?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- Who owns wound questions and aftercare outside office hours?Saving keeps this on your device and needs JavaScript, which is off in this browser.
Was RECELL studied alone or as part of a package?
The pivotal RECELL area received ablative-laser preparation and both the RECELL and control areas later received narrowband UVB. The study therefore supports that complete procedural package versus narrowband UVB alone. It cannot isolate the effect of the cell suspension from laser preparation or establish equivalent results without aftercare phototherapy. Evidence Evidence
Why this matters
This design matters when interpreting the result. It supports a difference between the complete RECELL-side package and the matched control, not a claim that sprayed cells alone caused every difference.
Questions for an experienced procedural specialist
- Which exact components match the pivotal study?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- Why is narrowband UVB part of the planned aftercare?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- What is evidence-based and what is this center’s extrapolation?Saving keeps this on your device and needs JavaScript, which is off in this browser.
What remains unknown, and how should I use patient stories?
The study was small. It does not establish outcomes for children, active disease, lips, eyelids, palms, soles, every skin tone, every center, or long-term color match and durability. Patient stories may explain recovery and access burden, but they cannot establish typical benefit or procedural safety. Evidence Evidence
Why this matters
Patient stories can help you ask about pain, dressings, time off, donor-site appearance, travel, center communication, patchy results, and emotional recovery. Those practical details deserve attention when clearly labelled as one person’s experience.
Questions for an experienced procedural specialist
- What outcome and follow-up are not established?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- How will we take comparable photos without treating them as a diagnosis?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- What other stable-vitiligo and no-treatment paths remain reasonable?Saving keeps this on your device and needs JavaScript, which is off in this browser.
Questions that can change the next decision
- For the procedural specialistHow was each patch you would treat shown to be stable?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- For the procedural specialistWhich parts of the complete package have evidence for my body sites?Saving keeps this on your device and needs JavaScript, which is off in this browser.
- For the center and payerWhat written quote and coverage decision include every part of the procedure and aftercare?Saving keeps this on your device and needs JavaScript, which is off in this browser.
Evidence snapshot
The FDA decision rests on a small randomized within-person study of the complete laser, RECELL, and later phototherapy package for selected stable adult lesions.
- Design
- Twenty-five adults each contributed matched RECELL and control areas.
- Procedure
- The RECELL side received laser preparation and the cell suspension; both sides later received NB-UVB.
- Outcome
- Substantial repigmentation favored RECELL areas; no studied area reached complete repigmentation.
- Limits
- Small population, selected stable lesions, site exclusions, and unresolved long-term durability.
Applicability check
Who was studied?
These fields show what the cited evidence reports about the people and body sites behind outcome or safety claims. “Not reported” means the reviewed source omitted the field; “Pending exact source review” means SteadySkin has not made that determination yet.
At week 24, 9 of 25 RECELL areas reached at least 80% repigmentation versus 0 of 25 matched controls. That was the pivotal within-person randomized study of 25 adults with stable focal, segmental, or generalized vitiligo. Fourteen of 25 RECELL areas, or 56%, reached more than 50% repigmentation versus 3 of 25 controls, or 12%. No studied area reached complete repigmentation.
- Age range
- Adults.
- Condition subtype
- Stable focal, segmental, and generalized vitiligo.
- Severity or extent
- Participants had selected stable lesions, limited total depigmented body-surface involvement, and unsatisfactory response to earlier topical or phototherapy care.
- Sample size
- 25 adults each contributed matched RECELL and control areas.
- Geography and care setting
- Ten procedural study sites.
- Skin tone or phototype
- Not reported
- Race
- FDA reported 80% White, 12% Asian, and 8% African American participants.
- Ethnicity
- Not reported
- Body sites
- Head, neck, dorsal hands, dorsal feet, arms, legs, trunk, and other areas were studied.
What that means for this page: The small study supports the complete studied package for selected stable adult lesions. It does not establish outcomes for active disease, children, excluded body sites, every skin tone, every center, or RECELL without laser preparation and later phototherapy.
RECELL is contraindicated for known hypersensitivity to trypsin or compound sodium lactate, also called Hartmann’s solution. The instructions also say skin-sample collection should not be used when there is known hypersensitivity to anesthetics, adrenaline or epinephrine, povidone-iodine, or chlorhexidine. The procedure adds a donor wound, ablative-laser resurfacing, anesthesia, dressings, and wound aftercare. Reported or labeled concerns include scarring, hypertrophic scarring, redness, itching, infection, Koebner phenomenon, worsening vitiligo, and limits for several body sites and populations. The Koebner phenomenon is the name for patches that develop where previously unaffected skin was injured. A procedure injures skin on purpose, at the donor site and at the treated one.
- Age range
- Adults.
- Condition subtype
- Stable vitiligo.
- Severity or extent
- Not reported
- Sample size
- 25 adults in the pivotal safety population.
- Geography and care setting
- Not reported
- Skin tone or phototype
- Not reported
- Race
- Not reported
- Ethnicity
- Not reported
- Body sites
- The instructions state that safety and effectiveness are not established for several sites including lips, eyelids, palms, and soles.
What that means for this page: The FDA record provides trial and device-package safety boundaries. The small population cannot supply a precise personal event rate or establish safety in excluded populations, body sites, active disease, or every procedural center.
Evidence behind this page
Sources
Each evidence badge opens the source and its limits. The full list stays available here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports FDA authorization of this device for repigmentation of stable depigmented vitiligo lesions in a defined adult population and trained professional setting.
What it does not support
It does not approve every grafting procedure, define stability for a reader or guarantee color match, durability or satisfaction.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: FDA authored the regulatory summary, while the pivotal evidence was manufacturer-sponsored and submitted. The decision record is authoritative but the underlying clinical evidence is not independent.
What this source supports
Supports the FDA-reviewed device description, pivotal within-person randomized study of 25 adults, population and body sites, absolute repigmentation outcomes, adverse events, contraindications, limitations, and the fact that the studied RECELL area also received ablative-laser preparation and later narrowband UVB.
What it does not support
The study cannot isolate the cell suspension from laser preparation, establish use without later phototherapy, predict an individual result, prove complete repigmentation, or establish current authorization outside the US.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: FDA hosts the approved instructions supplied by the device manufacturer. They control product use but are not independent comparative evidence.
What this source supports
Supports the trained-professional setting, donor-skin processing, ablative-laser surface preparation, contraindications, warnings, aftercare responsibilities, and body-site and population limitations in the approved US instructions.
What it does not support
The instructions do not select a patient, center, lesion, laser, aftercare plan, or predict response, color match, recovery, or coverage.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- AVITA MedicalManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: AVITA manufactures RECELL and issued the announcement. It is first-party scope information, not independent evidence or a regulator-hosted certificate.
What this source supports
Supports the manufacturer’s statement that RECELL GO obtained an EU-MDR CE mark for described acute-wound uses. It does not state a current vitiligo scope for that model.
What it does not support
A company announcement is not the model-specific certificate or instructions for use and cannot establish a current EU or UK vitiligo indication.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- Pigment Cell & Melanoma Research (Ezzedine K, et al.)Guideline · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports separating segmental vitiligo from nonsegmental forms and recognizing mixed and initially unclassified presentations. Classification is a clinical and longitudinal judgment. Its section on the Koebner phenomenon supports defining that phenomenon as patches developing at sites of previously unaffected skin that was specifically injured. It endorses the Vitiligo European Task Force classification of that phenomenon into history-based, clinical-observation-based and experimentally induced forms. Its section on mucosal vitiligo defines that term as the oral or genital mucosae. Where the patches are at one site alone, and especially a genital one, that section says a differential diagnosis of lichen sclerosus should be addressed by biopsy. It records that genital lichen sclerosus and vitiligo have been reported together.
What it does not support
It does not support self-classification from symmetry, one patch or a photograph, and it does not predict an individual response. On the Koebner phenomenon it records a general impression that the phenomenon and disease stability are related, then states that objective data are lacking. It also says scientific evidence is lacking for attributing vitiligo to daily friction from washing, dressing, personal care, sports, occupational activity or pressure from clothing. On lichen sclerosus it cites one reference from 2000 and calls a link a possibility, not a finding. It counts nothing and gives no rate.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.