Skin surgery for cutaneous injuries and defects

Skin is our body’s largest organ. Worldwide, millions of people suffer from large, deep skin defects requiring surgical interventions to restore skin function. Skin defects can be acute (burns and trauma) or elective (scar revisions, giant nevi or tumor resections, plastic surgery, etc.).

Burns are a global public health problem and major cause of death and disability globally, and number of plastic surgeries and skin cancers is growing globally.

The current standard of care in burn, plastic and reconstructive surgery – autografting – is often not available in sufficient quantities due to donor site shortage and yields skin grafts that are too thin and too often result in permanent painful, debilitating, disfiguring scars that frequently require follow up corrective surgeries, psychosocial rehabilitation and intense home care.

Clinical development program

denovoSkin™ is being clinically tested on burns and reconstructive indication in children and adults.

Phase I
Phase II
Phase III

Phase I Clinical Trial – Safety Study

A phase I clinical trial for denovoSkin™ was completed with a five-year follow-up period in 2021, with 10 paediatric patients at the University Children’s Hospital Zurich, Switzerland. This study assessed the safety of the product in children and adults who had to undergo skin transplantation due to acute burns or reconstructive surgeries. An area of the wounds of the patient were treated with a maximum of one denovoSkin™ graft. The study was successfully completed, confirming the product’s safety in this first-in-man clinical trial.

Phase II Clinical Trials – Safety and Efficacy Studies

Following the successful completion of the phase I clinical trial, denovoSkin™ is further evaluated for its safety and efficacy in three parallel phase II clinical trials. These trials are very similar in their design, but differ in the patient population and indication. In all three phase II clinical trials, denovoSkin™ is compared to today’s standard of care, the transplantation of autologous split-thickness skin. For this, two comparable wound areas are selected, and one of the areas is treated with a maximum of one denovoSkin™ graft, and the other area with the standard of care. During the study visits, the two areas are analyzed and compared, for a total of 3 years.

Phase III Clinical Trial – Safety and Efficacy Study

Following the anticipated successful completion of the phase II clinical trial for denovoSkin™ for burns in adults, a phase III clinical trial will be performed to further confirm the product’s safety and efficacy. This clinical trial is currently in preparation.

Named-patient basis treatment

Under special circumstances, there is a treatment option that allows the use of an unauthorised medicine, such as denovoSkin™ at its current development stage. Under strict conditions, denovoSkin™ can be made available directly from CUTISS to a physician treating a patient who suffers from a severe condition with no satisfactory authorised therapies and who cannot enter clinical trials. This is done on an individual basis under the direct responsibility of the doctor.

If you are a healthcare professional requesting more information on a potential named-patient treatment, please contact CUTISS.

Clinical and scientific publications

November 2023

Nature Reviews Disease Primers - Abstract
Jeschke M, Wood F, Middelkoop E, Bayat A., Teot L, Ogawa R, Gauglitz G. nature reviews disease primers. 2023 Nov;(9): 64

April 2023

Life threatening non-accidental burns, pandemic dependent telemedicine, and successful use of cultured Zurich Skin in a neonate – A case report.
Schiestl C, Zamparelli M, Meuli M, Hartmann-Fritsch F, Cavaliere A, Neuhaus K, Reichmann E, Böttcher-Haberzeth S. Burns Open. 2023 Apr;7(2):28-32.

July 2021

First time compassionate use of laboratory engineered autologous Zurich skin in a massively burned child
Moiemen N, Schiestl C, Hartmann-Fritsch F, Neuhaus K, Reichmann E, Löw A, Stenger C, Böttcher-Haberzeth S, Meuli M. Burns Open. 2021 Jul;5(3):113-117.

July 2021

Expanding into the future: Combining a novel dermal template with distinct variants of autologous cultured skin substitutes in massive burns
Schiestl C, Meuli M, Vojvodic M, Pontiggia L, Neuhaus D, Brotschi B, Reichmann E, Böttcher-Haberzeth S, Neuhaus K. Burns Open. 2021 Jul;5(3):145-153.

July 2021

Assessment of Non-cultured Autologous Epidermal Cell Grafting Resuspended in Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism Lesions: A Randomized Clinical Trial.
Bertolotti A, Leone G, Taïeb A, Soriano E, Pascal M, Maillard H, Van Geel N. Acta Derm Venereol. 2021 Jul;101: adv00506

July 2019

A Cultured Autologous Dermo-epidermal Skin Substitute for Full-Thickness Skin Defects: A Phase I, Open, Prospective Clinical Trial in Children
Meuli M, Hartmann-Fritsch F, Hüging M, Marino D, Saglini M, Hynes S, Neuhaus K, Manuel E, Middelkoop E, Reichmann E, Schiestl C. Plast Reconstr Surg. 2019 Jul;144(1):188-198.

December 2017

The Effect of Wound Dressings on a Bio-Engineered Human Dermo-Epidermal Skin Substitute in a Rat Model
Hüging M, Biedermann T, Sobrio M, Meyer S, Böttcher-Haberzeth S, Manuel E, Horst M, Hynes S, Reichmann E, Schiestl C, Hartmann-Fritsch F. J Burn Care Res. 2017 Nov/Dec;38(6):354-364

May 2017

Factors affecting the mechanical behavior of collagen hydrogels for skin tissue engineering
Pensalfini M, Ehret A, Stüdeli S, Marino D, Kaech A, Reichmann E, Mazza E. J Mech Behav Biomed Mater. 2017 May;69:85-97

January 2014

Bioengineering dermo-epidermal skin grafts with blood and lymphatic capillaries
Marino D, Luginbühl J, Scola S, Meuli M, Reichmann E. Sci Transl Med. 2014 Jan 29;6(221)
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