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.

Do you have questions or would you like to receive more information, please send us a message:
clinicaltrials@cutiss.swiss

STUDY 1: BURNS IN ADULTS

Titel of the study:
A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety
and efficacy of an autologous bio-engineered dermoepidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults in comparison to autologous splitthickness 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. This study is performed in different countries and hospitals:

  • University Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands
  • University Hospitals Birmingham, United Kingdom

Two burned skin areas 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.

STUDY 2: BURNS IN CHILDREN

Titel of the study:
A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermoepidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in children in comparison to autologous splitthickness 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. This study is performed in different countries and hospitals:

  • University Children’s Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands
  • University Hospitals Birmingham, United Kingdom

Two burned skin areas 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.

STUDY 3: RECONSTRUCTIVE SURGERIES IN ADULTS AND CHILDREN

Titel 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 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. This study is performed in different countries and hospitals:

  • University Hospital Zurich, Switzerland
  • University Children’s Hospital Zurich, Switzerland
  • Red Cross Hospital Beverwijk, The Netherlands
  • University Hospital Amsterdam, The Netherlands
  • University Hospitals Birmingham, United Kingdom

Two burned skin areas 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.