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Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

Primary Purpose

Venous Ulcer

Status
Recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Bioengineered Artificial Mesenchimal Sheet (BAMS)
Standard treatment (Control)
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 Venous Ulcer

Eligibility Criteria

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

Inclusion Criteria: Signing of the informed consent (IC) after reading the patient information sheet. Over 18 years of both sexes. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2 Grade III injury on the Widmer scale. Independence and/or availability to go to the referral center on an outpatient basis. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3 Exclusion Criteria: Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms. Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5). Active neoplasia and/or being treated with cytostatics. Patients undergoing radiotherapy treatment in areas close to the lesion. Clinical signs of colonization or local infection of the lesion. Patients with more than one lesion compatible with UV in the same lower limb. Erysipelas. Infectious cellulite. Osteomyelitis. Lymphangitis. Chronic lymphedema. Therapy with corticosteroids or immunosuppressants. Venous ulcer grade I or II on the Widmer scale. Lesions close to possible or diagnosed cancerous lesions. Non-localized wounds in the lower extremities. Ongoing infection and/or sepsis. Critical ischemia in the lower limbs or other venous diseases of unknown origin. Immunocompromised patients. Dependent patients with severe mobility limitations. Dialysis patients.

Sites / Locations

  • Unidad de A.P. de AlfacarRecruiting
  • Unidad de A.P. de AtarfeRecruiting
  • Universidad de GranadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bioengineered Artificial Mesenchimal Sheet (BAMS)

Standard treatment (Control)

Arm Description

Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix

Standard treatment

Outcomes

Primary Outcome Measures

Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 24, 2023
Sponsor
Andalusian Network for Design and Translation of Advanced Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT05962931
Brief Title
Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
Official Title
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (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

5. Study Description

Brief Summary
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bioengineered Artificial Mesenchimal Sheet (BAMS)
Arm Type
Experimental
Arm Description
Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix
Arm Title
Standard treatment (Control)
Arm Type
Active Comparator
Arm Description
Standard treatment
Intervention Type
Biological
Intervention Name(s)
Bioengineered Artificial Mesenchimal Sheet (BAMS)
Intervention Description
Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.
Intervention Type
Procedure
Intervention Name(s)
Standard treatment (Control)
Intervention Description
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
Primary Outcome Measure Information:
Title
Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
Description
To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
Time Frame
Through study completion, an average of 1 year
Title
Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
Description
To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signing of the informed consent (IC) after reading the patient information sheet. Over 18 years of both sexes. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2 Grade III injury on the Widmer scale. Independence and/or availability to go to the referral center on an outpatient basis. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3 Exclusion Criteria: Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms. Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5). Active neoplasia and/or being treated with cytostatics. Patients undergoing radiotherapy treatment in areas close to the lesion. Clinical signs of colonization or local infection of the lesion. Patients with more than one lesion compatible with UV in the same lower limb. Erysipelas. Infectious cellulite. Osteomyelitis. Lymphangitis. Chronic lymphedema. Therapy with corticosteroids or immunosuppressants. Venous ulcer grade I or II on the Widmer scale. Lesions close to possible or diagnosed cancerous lesions. Non-localized wounds in the lower extremities. Ongoing infection and/or sepsis. Critical ischemia in the lower limbs or other venous diseases of unknown origin. Immunocompromised patients. Dependent patients with severe mobility limitations. Dialysis patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Férnández López, PhD
Phone
955 048 366
Ext
0034
Email
ensayosclinicos.radytta.fps@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Encarnación González Vigil
Organizational Affiliation
Unidad de A.P. de Atarfe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Ángeles Granado Contrelas
Organizational Affiliation
Unidad de A.P. de Alfacar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Costela Ruiz
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
Facility Information:
Facility Name
Unidad de A.P. de Alfacar
City
Alfacar
State/Province
Granada
ZIP/Postal Code
18170
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª Ángeles Granado Contrelas
Facility Name
Unidad de A.P. de Atarfe
City
Atarfe
State/Province
Granada
ZIP/Postal Code
18290
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Encarnación González Vigil
Facility Name
Universidad de Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Costela Ruiz

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

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