Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery

Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma

Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma

Study Overview

• Status: Recruiting
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Biological: PHIT; Biological: PHITAH; Biological: Skin Autograft

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Macarena Guijo Molero; Phone Number: 0034 671 537 264; Email: macarena.guijo@juntadeandalucia.es

Study Locations

• Spain
  • Granada, Spain, 18014
    • Recruiting
    • Hospital U. Virgen de las Nieves
    • Contact: Salvador Arias
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital U. Virgen de la Victoria
    • Contact: Ricardo Bosch
  • Sevilla, Spain, 4109
    • Recruiting
    • Hospital U. Virgen Macarena
    • Contact: David Moreno
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Recruiting
      • Hospital Costa Del Sol
      • Contact: Magdalena Troya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients that give their informed consent for study participation.
2. Adult (18 years of age or older), of any sex and racial origin.
3. 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.
4. Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.

Exclusion Criteria:

1. Locally advanced basal cell carcinoma with evidence of tissue infiltration.
2. Lesions in the face.
3. Injuries requiring urgent surgical intervention.
4. Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
5. Injuries that have received treatment with radiotherapy.
6. Contraindication for Mohs surgery.
7. Known allergies to Biobrane dressing.
8. Pregnant or breastfeeding women.
9. Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
10. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PHIT; Human artificial skin created by tissue engineering, composed of a sheet of autologous adult differentiated skin keratinocytes and fibroblasts expanded in a biological fibrin-agarose matrix (PHIT).	Biological: PHIT; Human artificial skin created by tissue engineering: fibrin-agarose
Experimental: PHITAH; Human artificial skin created by tissue engineering, composed of a sheet of keratinocytes and differentiated autologous adult skin fibroblasts expanded in a biological fibrin-hyaluronic matrix (PHITAH).	Biological: PHITAH; Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
Active Comparator: Skin Autograft; Skin autograft.	Biological: Skin Autograft; Skin Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of autologous bioengineered skin	Incidence of adverse events related to investigational medicinal products	Through study completion, an average of 2 year
Efficacy of autologous bioengineered skin	Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Andalusian Network for Design and Translation of Advanced Therapies

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: NanoGSkin-CB-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No