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

Primary Purpose

Basal Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
PHITAH
PHIT
Skin Autograft
Sponsored by
Andalusian Network for Design and Translation of Advanced Therapies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Costa del SolRecruiting
  • Hospital U. Virgen de las NievesRecruiting
  • Hospital U. Virgen de la VictoriaRecruiting
  • Hospital U. Virgen MacarenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

PHIT

PHITAH

Skin Autograft

Arm Description

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).

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).

Skin autograft.

Outcomes

Primary Outcome Measures

Safety of autologous bioengineered skin
Incidence of adverse events related to investigational medicinal products
Efficacy of autologous bioengineered skin
Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis

Secondary Outcome Measures

Full Information

First Posted
December 27, 2021
Last Updated
October 10, 2022
Sponsor
Andalusian Network for Design and Translation of Advanced Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT05234658
Brief Title
Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery
Official Title
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andalusian Network for Design and Translation of Advanced Therapies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PHIT
Arm Type
Experimental
Arm Description
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).
Arm Title
PHITAH
Arm Type
Experimental
Arm Description
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).
Arm Title
Skin Autograft
Arm Type
Active Comparator
Arm Description
Skin autograft.
Intervention Type
Biological
Intervention Name(s)
PHITAH
Intervention Description
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
Intervention Type
Biological
Intervention Name(s)
PHIT
Intervention Description
Human artificial skin created by tissue engineering: fibrin-agarose
Intervention Type
Biological
Intervention Name(s)
Skin Autograft
Intervention Description
Skin Autograft
Primary Outcome Measure Information:
Title
Safety of autologous bioengineered skin
Description
Incidence of adverse events related to investigational medicinal products
Time Frame
Through study completion, an average of 2 year
Title
Efficacy of autologous bioengineered skin
Description
Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis
Time Frame
Through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Macarena Guijo Molero
Phone
671 537 264
Ext
0034
Email
macarena.guijo@juntadeandalucia.es
Facility Information:
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Troya
Facility Name
Hospital U. Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador Arias
Facility Name
Hospital U. Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Bosch
Facility Name
Hospital U. Virgen Macarena
City
Sevilla
ZIP/Postal Code
4109
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Moreno

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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