NCT05234658
Recruiting
Phase 2
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Andalusian Network for Design and Translation of Advanced Therapies4 sites in 1 country21 target enrollmentJanuary 21, 2022
ConditionsBasal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Basal Cell Carcinoma
- Sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Safety of autologous bioengineered skin
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients that give their informed consent for study participation.
- •Adult (18 years of age or older), of any sex and racial origin.
- •Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps. Namely, indication for Mohs surgery.
- •Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.
Exclusion Criteria
- •Locally advanced basal cell carcinoma with evidence of tissue infiltration.
- •Lesions in the face.
- •Injuries requiring urgent surgical intervention.
- •Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
- •Injuries that have received treatment with radiotherapy.
- •Contraindication for Mohs surgery.
- •Known allergies to Biobrane dressing.
- •Pregnant or breastfeeding women.
- •Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
- •Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
Outcomes
Primary Outcomes
Safety of autologous bioengineered skin
Time Frame: Through study completion, an average of 2 year
Incidence of adverse events related to investigational medicinal products
Efficacy of autologous bioengineered skin
Time Frame: Through study completion, an average of 2 year
Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis
Study Sites (4)
Loading locations...
Similar Trials
Completed
Phase 1
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin DefectsBurn InjurySoft Tissue InjurySkin NecrosisScarsCongenital Giant NevusSkin TumorsNCT02145130University of Zurich12
Recruiting
Phase 1
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn TraumaBurnsNCT02350205CHU de Quebec-Universite Laval52
Completed
Phase 2
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic MalignanciesOral MucositisNCT00845819Seoul National University Hospital138
Active, not recruiting
Phase 2
A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)Squamous Cell CarcinomaNCT06041802Merck Sharp & Dohme LLC19
Completed
Phase 1
Treatment CLI Nonrevascularizable Lower Limb With Cell TherapyNonrevascularizable Critical Ischemia of the Lower LimbsNCT01824069Instituto de Investigación Hospital Universitario La Paz10