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

July 24, 2023 updated by: Andalusian Network for Design and Translation of Advanced Therapies

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Recruiting
        • Universidad de Granada
        • Contact:
          • Victor Costela Ruiz
    • Granada
      • Alfacar, Granada, Spain, 18170
        • Recruiting
        • Unidad de A.P. de Alfacar
        • Contact:
          • Mª Ángeles Granado Contrelas
      • Atarfe, Granada, Spain, 18290
        • Recruiting
        • Unidad de A.P. de Atarfe
        • Contact:
          • Encarnación González Vigil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signing of the informed consent (IC) after reading the patient information sheet.
  2. Over 18 years of both sexes.
  3. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
  4. Grade III injury on the Widmer scale.
  5. Independence and/or availability to go to the referral center on an outpatient basis.
  6. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3

Exclusion Criteria:

  1. 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.
  2. Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5).
  3. Active neoplasia and/or being treated with cytostatics.
  4. Patients undergoing radiotherapy treatment in areas close to the lesion.
  5. Clinical signs of colonization or local infection of the lesion.
  6. Patients with more than one lesion compatible with UV in the same lower limb.
  7. Erysipelas.
  8. Infectious cellulite.
  9. Osteomyelitis.
  10. Lymphangitis.
  11. Chronic lymphedema.
  12. Therapy with corticosteroids or immunosuppressants.
  13. Venous ulcer grade I or II on the Widmer scale.
  14. Lesions close to possible or diagnosed cancerous lesions.
  15. Non-localized wounds in the lower extremities.
  16. Ongoing infection and/or sepsis.
  17. Critical ischemia in the lower limbs or other venous diseases of unknown origin.
  18. Immunocompromised patients.
  19. Dependent patients with severe mobility limitations.
  20. Dialysis patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bioengineered Artificial Mesenchimal Sheet (BAMS)
Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix
Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS)
Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.
Active Comparator: Standard treatment (Control)
Standard treatment
Procedure: Standard treatment (Control)
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
Time Frame: Through study completion, an average of 1 year
To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
Through study completion, an average of 1 year
Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
Time Frame: Through study completion, an average of 1 year
To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andalusian Network for Design and Translation of Advanced Therapies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Encarnación González Vigil, Unidad de A.P. de Atarfe
  • Principal Investigator: Mª Ángeles Granado Contrelas, Unidad de A.P. de Alfacar
  • Study Director: Victor Costela Ruiz, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UV/AP/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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