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
Phase I (Safety) clinical trials for denovoSkin™ are completed with 5 years follow up (burn and reconstructive, children and adults)
Phase 2 (Safety and Efficacy) clinical trials for denovoSkin™ have completed enrollement in burns adults & adolescent and primary endpoint has been reached with statistical significance: BA
Phase 2 studies in reconstructive adult&children is close to enrollement completion: RAC
Phase 2 studies in pediatric burns are ongoing.: BC
Burn compassionate cases have also been treated.
Title of the study:
A Phase II, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety
and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults in comparison to autologous split-thickness skin grafts (STSG).
Summary:
The study examines and compares the safety and efficacy of a transplant product (denovoSkin) made from the patient’s own skin with the current standard method, i.e. the transplantation of a thin autologous skin graft (split-thickness skin graft), in patients who need a skin graft due to a skin burn.
General information on the study:
This study is being conducted in persons 12 years of age and older who require a skin graft due to a skin burn.
Two burned skin areas that need skin grafting are selected and based on a random distribution, one skin area will be treated with denovoSkin and the other with the patient’s own skin. During the visits after the transplantation, both grafts will be checked for their safety and efficacy.
The entire study lasts about 12 months per patient and includes 10 study visits. In addition, yearly follow-up visits take place after 2 and 3 years after transplantation.
This study is performed in different countries and hospitals, current study sites include:
Switzerland:
- Universitäts-Kinderspital Zürich
- Universitätsspital Zürich
The Netherlands:
- Rode Kruis Ziekenhuis Beverwijk
- Maasstad Ziekenhuis Rotterdam
Italy:
- Azienda Ospedale Università Padova
- Azienda Ospedaliera Universitaria Integrata Verona
- Ospedale Santobono, Napoli
- Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Napoli
Title of the study:
A Phase II, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in children in comparison to autologous split-thickness skin grafts (STSG).
Summary:
The study examines and compares the safety and efficacy of a transplant product (denovoSkin) made from the patient’s own skin with the current standard method, i.e. the transplantation of a thin autologous skin graft (split-thickness skin graft), in patients who need a skin graft due to a skin burn.
General information on the study:
This study is being conducted in persons younger than 12 years of age who require a skin graft due to a skin burn.
Two burned skin areas that need skin grafting are selected and based on a random distribution, one skin area will be treated with denovoSkin and the other with the patient’s own skin. During the visits after the transplantation, both grafts will be checked for their safety and efficacy. The entire study lasts about 12 months per patient and includes 10 study visits. In addition, yearly follow-up visits take place after 2 and 3 years after transplantation.
This study is performed in different countries and hospitals, current study sites include:
Switzerland:
- Universitäts-Kinderspital Zürich
The Netherlands:
- Rode Kruis Ziekenhuis Beverwijk
Italy:
- Azienda Ospedale Università Padova
- Azienda Ospedaliera Universitaria Integrata Verona
- Ospedale Santobono, Napoli
Title of the study:
A Phase II, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of full thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG).
Summary:
The study examines and compares the safety and efficacy of a transplant product (denovoSkin) made from the patient’s own skin with the current standard method, i.e. the transplantation of a thin autologous skin graft (split-thickness skin graft), in patients who need a skin graft due to reconstructive surgery. This can be for example due to a removal of a scar, a congenital nevus, a benign skin tumour, or due to a gender reassignment surgery.
General information on the study:
This study is being conducted in persons from 1 year of age who require a skin graft due to a reconstructive surgery. Two skin areas that need skin grafting are selected and based on a random distribution, one skin area will be treated with denovoSkin and the other with the patient’s own skin. During the visits after the transplantation, both grafts will be checked for their safety and efficacy.
The entire study lasts about 12 months per patient and includes 10 study visits. In addition, yearly follow-up visits take place after 2 and 3 years after transplantation.
This study is performed in different countries and hospitals, current study sites include:
Switzerland:
- Universitäts-Kinderspital Zürich
- Universitätsspital Zürich
The Netherlands:
- Rode Kruis Ziekenhuis Beverwijk
- VU University Medical Center Amsterdam
Italy:
- Azienda Ospedale Università Padova
- Azienda Ospedaliera Universitaria Integrata Verona
- Ospedale Santobono, Napoli
- Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Napoli
Significant need for patients with severe burns
Annually, at least 11 million patients suffer from severe burns and require skin surgery to restore skin function.
When patients suffer from disastrous large and deep burns, the ability to quickly, affordably and consistently provide large quantities of skin grafts is essential.
Survival from major burns is closely related to how fast definitive wound closure is achieved. After surgery, quality of life must take center stage in patients’ management and support.
Speeding and scaling up the culturing process of bio-engineered, personalized skin grafts that minimally scar can be a game changer for saving the lives of patients with major burns. At the same time, patients’ healthy skin donor sites can be spared, and the post-treatment quality of life is superior compared to current standard of care. This also applies to skin treatment beyond burns.
Clinical and scientific publications
2022
2021
2021
2019
2017
2016
Clinical and scientific publications
April 2023
July 2021
July 2021
July 2021
July 2019
November/December 2017
May 2017
January 2014
Significant need for patients with severe burns
Annually, at least 11 million patients suffer from severe burns and require skin surgery to restore skin function.
When patients suffer from disastrous large and deep burns, the ability to quickly, affordably and consistently provide large quantities of skin grafts is essential.
Survival from major burns is closely related to how fast definitive wound closure is achieved. After surgery, quality of life must take center stage in patients’ management and support.
Speeding and scaling up the culturing process of bio-engineered, personalized skin grafts that minimally scar can be a game changer for saving the lives of patients with major burns. At the same time, patients’ healthy skin donor sites can be spared, and the post-treatment quality of life is superior compared to current standard of care. This also applies to skin treatment beyond burns.
