Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers

May 2, 2022 updated by: Szeged University
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This motive trial can help to establish routine application of this internationally widely used device at University of Szeged. The primary outcome is the reduction rate of the wound size. The treatment response will be calculated from wound size before and after treatment. Any adverse events related to the study device will be monitored.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

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 Locations

  • Hungary
      • Szeged, Hungary, 6720
        • Recruiting
        • University of Szeged Department of Dermatology and Allergology
        • Contact:
          • Lajos Kemény, Prof. Dr.
        • Principal Investigator:
          • Balázs Bende, MD
        • Sub-Investigator:
          • Győző Szolnoky, MD, PhD
        • Principal Investigator:
          • Lajos Kemény, Prof. MD.
        • Sub-Investigator:
          • Zoltán Veréb, Ph.D.

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent
  2. Males or females age ≥ 18
  3. At least one venous chronic leg ulcer with the following condition 3.1. Ulcer is present beyond 2 months 3.2. Conservative treatment not leading to improvement 3.3. Wound size between ≥5 and ≤100 cm2
  4. Ability to safely undergo tissue harvest that is anticipated to yield >100mL of adipose tissue at a site that is free from infection and injury
  5. Able and willing to work with the doctor, adhere to therapeutic prescriptions and appear on prescribed examinations
  6. Normal or clinically not significant abnormal values based on investigator judgement on white blood cell count (WBC), C-reactive protein (CRP), Platelets, international normalized ratio (INR), partial thromboplastin time (APTT), haemoglobin (Hgb), Renal and Liver function
  7. Females of childbearing potential must have a negative pregnancy test at the Screen Visit
  8. Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which has a proven low failure rate of less than 1%

Exclusion Criteria:

  1. More than 20% change in surface area of target ulcer between screening and enrollment visit.
  2. There is bone involvement in case of ulcer
  3. Patient with a history of bleeding disorder
  4. Therapy for anticoagulation
  5. Patient receiving corticosteroids, immunosuppressive or cytotoxic agents, and all systemic agents that can affect wound repair
  6. Patient with any treatment that might interfere with the assessment of the study treatment
  7. Pregnant or likely to become pregnant or lactating women
  8. Participation in any type of clinical investigation concurrently or in the last 6 months
  9. Positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) and syphilis (results within 1 month are acceptable)
  10. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for the participation in the study.
  11. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study (except basal cell skin cancer)
  12. Patient currently undergoing dialysis for renal insufficiency (serum creatinine ≥2 mg/dL)
  13. In the opinion of treating physician, patient not expected to survive beyond 30 days
  14. Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
  15. Uncontrolled chronic disease
  16. Patient with history of severe alcohol or drug abuse
  17. Lack of patient's cooperation
  18. Use with blood thinners within 8 weeks of enrollment

  19. Systemic treatments with a possible effect on ulcers within 4 weeks prior to enrollment with the following exceptions:

    1. Ustekinumab (within 16 weeks prior to enrollment)
    2. Adalimumab, infliximab, alefacept (within 8 weeks prior to enrollment)

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cytori Celution System in Chronic Non-Healing venous Leg Ulcers
On the screening visit, the study physician will assign one eligible ulcer, as the target ulcer. Target ulcer will be treated and followed up during the whole study period. After liposuction investigational device will be applied on the target ulcer. After completion of Day1 visit all subjects enter the observation period and will come back to 3 on-site visits on day 7 day 14 and day 28
Device: Venous leg ulcer treatment with adipous SVF
The Celution® System isolates approximately maximum 30 million SVF cells per 100 mL of adipose tissue to be processed. Approximately 1-3 million cells per injection (total 8-30) will be administered locally, in the target ulcer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction rate of the wound size
Time Frame: 28 days
The treatment response will be calculated from wound size before and after treatment.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound closure at Day 28
Time Frame: 28 days
Percentage of patients achieving 50% wound closure at Day 28
28 days
Improvement of Quality of Life (QoL) - EQ-5D-5L
Time Frame: 28 days
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
28 days
Improvement Wound pain
Time Frame: 28 days
Improvement Wound pain visual analogue scale (VAS)
28 days

Collaborators and Investigators

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

Sponsor

Szeged University

Investigators

  • Principal Investigator: Balázs Bende, MD, Szeged University
  • Principal Investigator: Lajos Kemény, Prof. Dr., Szeged University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

November 29, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZTE-CCS-LUL-01

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

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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