Treatment of wound in the course of Epidermolysis Bullosa, chronic venous leg ulceration and thermal injury by biological dressing made of mesynchemal stem cells seeded on acellular human skin.
- Conditions
- BIOOPA dressing will be used in the treatment of wounds in the course of Epidermolysis Bullosa, chronic venous leg ulceration and thermal injury (second degree burn).MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003890-91-PL
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Inclusion criteria for Epidermolysis Bullosa Cohort:
1)Signed written informed consent prior to beginning study- related procedures.
2)Male or female:
a)Children, aged 5 - 18 years at date of inclusion into the study
b)Adults, aged 18 – 60 years at date of inclusion into the study
3)Established clinical diagnosis of recessive, severe, generalized type of EB (dystrophic and joint types)
4)Skin wound, which:
a)is located on the trunk or extremities,
b)is not healing for period of minimum 3 weeks
c)with a surface area between 3 – 30 cm2 (children), 10 – 30 cm2 (adults)
Inclusion criteria number 4) for Patients with at least two open skin wounds of similar size:
4)two open skin wounds of similar size (surface area difference +/– 15%), which:
a)are located on the trunk and/or extremities,
b)are not healing for period of minimum 3 weeks
c)each with a surface area between 3 – 30 cm2 (children), 10 – 30 cm2 (adults)
Inclusion Criteria for Venous Leg Ulcers Cohort:
1)Signed written informed consent prior to beginning study- related procedures.
2)Male or female, aged 40 – 80 years at date of inclusion into the study
3)Presence of a venous leg ulcer (VLU) between the knee and ankle:
a)with a surface area between: 25 cm2 - 100 cm2
b)that has been present for at least 3 month
4)Adequate circulation to the affected lower extremity, defined as an Ankle Brachial Index (ABI) greater than 0.75.
5)Venous insufficiency confirmed by duplex Doppler ultrasound.
6)Have a Clinical severity, Etiology or cause, Anatomy and Pathophysiology ulcer classification (CEAP) Grade C6: an open venous ulcer.
Inclusion Criteria for Thermal Injury Cohort:
1)Signed written informed consent prior to beginning study- related procedures.
2)Male or female adults, aged 18 – 60 years at date of inclusion into the study
3)Patient with second-degree burn (II) or third-degree burn (III) wound (s) caused by thermal injury
4)Target burn wound surface area: 5 – 50 cm2
5)The area of total burn injury below 10% TBSA.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria for Epidermolysis Bullosa Cohort:
1)Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
2)Chronic or current active infection or disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis B, active Hepatitis C, and known Human Immunodeficiency Virus (HIV) disease. All HIV-positive subjects are excluded from this trial
3)EB target wound with clinical signs (e.g. wound exudate) of local infection at day of baseline visit.
4)Administration of immunosuppressive agents. Use of systemic steroids within 30 days before baseline visit should be discussed with Lead Principal Investigator to determine patient’s eligibility.
5)Current and/or former malignancy including basal cell carcinomas and squamous cell carcinomas.
6)Enrolment in any interventional study or treated with any investigational drug for any disease within 4 weeks prior to study entry.
7)Pregnant or nursing women.
Exclusion criteria for Venous Leg Ulceration Cohort:
1)Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
2)Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis B, active Hepatitis C, and known Human Immunodeficiency Virus (HIV) disease. All HIV-positive subjects are excluded from this trial.
3)Documented history of osteomyelitis at the target wound location within 6 months preceding the Baseline Visit.
4)Clinical evidence (e.g. wound exudate) of target ulcer infection at the day of baseline visit.
5)Administration of immunosuppressive agents. Use of systemic steroids within 30 days before baseline visit should be discussed with Principal Investigator to determine patient’s eligibility.
6)Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
7)Taking, or have participated in other clinical studies involving stem cell therapy.
8)Enrolment in any interventional study or treated with any investigational drug for any disease within 4 weeks prior to study entry.
9)Ulcer, which in the opinion of the Investigator is suspicious for cancer.
10)Current and/or former malignancy.
11)Poorly controlled type 2 diabetes mellitus defined as with glycosylated haemoglobin (HbA1c >7,0%)
12)Pregnant or nursing women.
Exclusion Criteria for Burn Cohort
1)Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
2)Airway burns.
3)Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis B, active Hepatitis C, and known Human Immunodeficiency Virus (HIV) disease. All HIV-positive subjects are excluded from this trial.
4)Administration of immunosuppressive agents. Use of systemic steroids within 30 days before baseline visit should be discussed with Principal Investigator to de
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method