Cutiss AG

Large, deep Skin Defects

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.).
Current standard of care to treat large, deep skin defects is very often not available in sufficient quantities, and it frequently leaves these patients with permanent, painful, disfiguring, and debilitating scars.

Today’s standard of care consists in harvesting a thin layer of healthy patient’s skin (autograft), composed of epidermis but only remnants of the dermis. Human skin is mainly composed of an outer epidermis and a lower dermis and the components of the dermis control and regulate scarring. Since sufficient dermis is missing in the autografts, the clinical outcome is too often a scar. Scars may impair mobility and growth, and often require several follow-up surgeries, intense homecare and psychosocial rehabilitation.

Cutiss AG

Clinical Problem – Scars

Worldwide, millions of people suffer from severe skin defects requiring surgical interventions to restore skin function. Existing therapies frequently leave these patients with permanent, painful, disfiguring, and debilitating scars. Scars may impair mobility and growth, and often require several follow-up surgeries, intense homecare and psychosocial rehabilitation.

Human skin is mainly composed of an outer epidermis and a lower dermis. The components of the dermis control and regulate scarring. Today, standard of care consists in harvesting a thin layer of healthy patient’s skin (autograft), which contains the epidermis but only remnants of the dermis. Since sufficient dermis is missing, these autografts often develop into scars.

Cutiss AG

For Patients

Currently, denovoSkin is tested in three Phase II clinical trials, to evaluate the safety and efficacy of the product. The three trials are almost identical, but differ in patient populations and indications. Below, the three trials are presented.

Title of the study:
A Phase IIb, 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 18 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:

  • University Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands

Title of the study:
A Phase IIb, 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 of 1-17 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:

  • University Children’s Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands

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:

  • University Hospital Zurich, Switzerland
  • University Children’s Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands
  • VU University Medical Centre Amsterdam, The Netherlands
Cutiss AG

For Health Professionals

Currently, denovoSkin is tested in three Phase II clinical trials, to evaluate the safety and efficacy of the product. The three trials are almost identical, but differ in patient populations and indications. Below, the three trials are presented.

Title of the study:
A Phase IIb, 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 18 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:

  • University Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands

Additional Information:
Additional information on this study can be found in the international study register of the WHO

Title of the study:
A Phase IIb, 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 of 1-17 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:

  • University Children’s Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands

Additional Information:
Additional information on this study can be found in the international study register of the WHO

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 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:

  • University Hospital Zurich, Switzerland
  • University Children’s Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands
  • VU University Medical Centre Amsterdam, The Netherlands

Additional Information:
Additional information on this study can be found in the international study register of the WHO

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