Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2021-03-31

Brief Summary

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The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.

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Detailed Description

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Conditions

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Burn Injury Soft Tissue Injury Skin Necrosis Scars Congenital Giant Nevus Skin Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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denovoDerm

Autologous tissue-engineered dermal substitute

Group Type EXPERIMENTAL

denovoDerm

Intervention Type BIOLOGICAL

Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin

denovoSkin

Autologous tissue-engineered dermo-epidermal skin substitute

Group Type EXPERIMENTAL

denovoSkin

Intervention Type BIOLOGICAL

Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed

Interventions

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denovoDerm

Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin

Intervention Type BIOLOGICAL

denovoSkin

Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:

1. Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
2. Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours
* Informed consent by patients/parents or other legal representatives

Exclusion Criteria

* Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
* Patients tested positive for HBV, HCV, syphilis or HIV
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
* Coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN and / or at the Investigator's discretion
* Previous enrolment of the patient into the current study
* Participation of the patient in another study within 30 days preceding and during the present study
* Patients or parents/other legal representatives expected not to comply with the study protocol
* Suspicion of child abuse
* Pregnant or breast feeding females
* Contamination derived from biopsy which could interfere with patients health
* Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
* Skin substitute has not been released due to production specific deviations
* Patients allergic to amphotericin B and gentamicin

Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No