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Skin Ulcer Venous Stasis ChronicPhase 1/2NCT02742844

Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers

A Phase 1/2 study testing APZ2 application in people with Skin Ulcer Venous Stasis Chronic, run by RHEACELL GmbH & Co. KG at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Skin Ulcer Venous Stasis Chronic
What is being tested?
APZ2 application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesGermany
Study dates
Aug 2016to 15 Jan 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 18 to 85 years;
  • Chronic venous leg ulcer (as defined by the current AWMF guidelines: therapy resistant ulcer that shows no improvement within 3 months despite of optimal phlebological therapies or is not healed within 12 months) for at least 6 weeks but shorter than 3 years diagnosed by doppler ultrasonography (DUS), ankle brachial index (ABI, 0.9-1.3), physical examination and dermatological review;
  • Wound size between 5 and 50 square cm measured by a standardized photography at the screening visit;
  • Wound location between knee and ankle;
  • Patients suffering from 2 ulcers at the same extremity, as long as these ulcers are separated by a minimum bridge of 1 cm of epithelialized skin;
  • Patients must agree to have at least one biopsy performed before treatment. In case IMP production from the first biopsy is not successful, a second biopsy will be taken;
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  • Body mass index (BMI) between 20 and 40 kg/m²;
  • Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure;
  • Women of childbearing potential must have a negative blood pregnancy test at Screening and at Visit 5 before the IMP application;
  • Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial.

Who cannot join

  • General exclusion criteria
  • Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
  • Current long-term use (more than 14 days) of steroid medication above Cushing-threshold dose (>7.5 mg/d prednisone or equivalent);
  • Diabetes mellitus that has to be evaluated by blood test (Hemoglobin A1c [HbA1c] > 7.5%);
  • Peripheral Artery Disease (PAD) including claudication with need of treatment;
  • Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep vein thrombosis;
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  • Unable to tolerate leg ulcer compression bandage;
  • Infection of the target ulcer requiring treatment as judged clinically;
  • Wound size <1.5 cm² measured by a standardized photography at Visit 5;
  • Any chronic dermatological disorders diagnosed at the investigator's discretion;
  • Skin disorders, unrelated to the ulcer, that are present adjacent to the target wound;
  • Current use of medications that influence wound healing: systemic immunosuppressives, cytotoxic medicinal products, and systemic steroids (above Cushing-threshold level);
  • Known abuse of alcohol, drugs, or medicinal products;
  • Cancerous or pre-cancerous lesions adjacent to the target wound;
  • Patients anticipated to be unwilling or unable to comply with the requirements of the protocol;
  • Pregnant or lactating women;
  • Systemic infectious disease diagnosed by serology testing for syphilis (acute), human immunodeficiency virus (HIV˗1, HIV-2), hepatitis B (acute) or C infection at Screening or at Visit 2;
  • Any known allergies to components of the IMP;
  • Prior surgical procedures such as bypass or mesh-graft treatment within 2 months prior to IMP application;
  • Treatment with active wound care agents (e.g. Iruxol, local antibiotics or silver dressings), which have not been paused 14 days before IMP application;
  • Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
  • Previous participation in this clinical trial;
  • Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient's compliance, or place the patient at high risk of complications related to the treatment;
  • Employees of the sponsor, or employees or relatives of the investigator.
  • A wound size enlargement of more than 25% between the wound assessment at the screening visit and the wound assessment at Visit 5;
  • A wound size reduction of more than 50% between the wound assessment at the screening visit and wound assessment at Visit 5.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken, Kliniken der Ruhr-Universität Bochum im St. Maria-Hilf-Krankenhaus

    Bochum, 44805

  • Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: An Interventional, Single Arm, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of APZ2 on Wound Healing of Chronic Venous Ulcer (CVU)

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.

Read the detailed description

This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of ABCB5+ mesenchymal stem cells (MSCs) on wound healing in patients with chronic venous ulcer (CVU). Autologous MSCs will be isolated ex vivo from a small skin biopsy and will be expanded in vitro. The IMP APZ2 containing the ABCB5+ cells will then be applied on the wound surface of CVU under local anesthesia.

Patients are followed up for efficacy for 3 months which allows to distinguish actual wound healing from transient wound coverage.

The wound healing process will be documented by standardized photography. The wound size evaluation will start on the day of the first change of wound dressing. The quality of the wound healing process will be assessed on the basis of formation of granulation tissue, epithelialization and wound exudation.

Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires. To assess long-term safety of APZ2 an additional follow-up visit at Month 12 post IMP application is included.

Being tested
APZ2 application
Keywords
phase I/IIa, mesenchymal stem cells, ABCB5+, APZ2, chronic venous ulcer, varicose ulcer, skin ulcer, advanced therapy medicinal product, APZ2-II-01, autologous use, somatic cell therapy
Medical subject headings
Varicose Ulcer, Skin Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APZ2 applicationBiological

    Application of IMP on patients wound.

Study groups in NCT02742844
Study groupRoleWhat they receive
APZ2 applicationExperimentalTopical, single application of APZ2; 500000 cells per square cm;
Receives: Biological: APZ2 application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of wound size reduction

    Percentage of wound size reduction at Week 12, or last available post-baseline measurement if the Week 12 measurement is missing (last observation carried forward [LOCF])

    Measured: Week 12 post baseline, or last available post-baseline measurement if the Week 12 measurement is missing

  2. Assessment of adverse event (AE) occurrence

    All during the clinical trial occurring AEs will be registered, documented and evaluated.

    Measured: At biopsy removal, 1-3 days post biopsy, 7-10 days post biopsy, 6-12 weeks post biopsy; at baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 and month 12 post baseline

Secondary outcomes (12)

  1. Percentage of wound size reduction

    Percentage of wound size reduction at Weeks 2, 3, 4, 6, 8, 10 and 12 (without LOCF)

    Measured: Weeks 2, 3, 4, 6, 8, 10 and 12 post baseline

  2. Absolute wound size reduction

    Measured: Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline

  3. Proportion of patients achieving complete wound closure

    Measured: Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline and at any time point up to week 12

  4. Time to first complete wound closure

    A priori specification not possible

    Measured: Between baseline and week 12 post baseline

  5. Proportion of patients achieving 30% wound closure

    Measured: Weeks 2, 3, 4, 6, 8, 10, 12 post baseline and at any time point up to week 12

  6. Time to first 30% wound closure

    A priori specification not possible

    Measured: Between baseline and week 12 post baseline

  7. Percentage of wound epithelialization

    Amount of wound epithelialization in % of wound area will be assessed by the investigator based on image analysis of images taken from the wound.

    Measured: At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline

  8. Formation of granulation tissue and wound exudation

    Formation of granulation tissue in % of wound area will be assessed by the investigator based on image analysis of images taken from the wound.

    Wound exudation will be classified by the investigator using following scores:

    • High: Small amounts of fluid or free fluids are visible when the dressing is removed; dressing is extensively marked or wet
    • Moderate: Small amounts of fluid are visible when dressing is removed; wound bed may appear glossy; Primary dressing may be lightly marked
    • Low: Wound bed is dry; there is no visible moisture; Primary dressing is unmarked; dressing may be adherent to wound

    Measured: At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline

  9. Pain assessment as per numerical rating scale (NRS)

    Measured: At baseline and days 1-3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline

  10. Quality of life (QoL) assessment using the SF-36 questionnaire

    Measured: At baseline and weeks 4, 8, 12 post baseline

  11. Dermatologic quality of life assessment using the DLQI questionnaire

    Measured: At baseline and weeks 4, 8, 12 post baseline

  12. Physical examination and vital parameters

    Measured: At Screening, baseline, week 12, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion15 Jan 2019
  4. Study completion15 Jan 2019

Why it stopped: COVID-19 pandemic and patient recruitment issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02742844
Sponsor's protocol ID
APZ2-II-01
Status last verified
Feb 2020
First submitted
7 Apr 2016
Last updated
7 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing APZ2 application in people with Skin Ulcer Venous Stasis Chronic, run by RHEACELL GmbH & Co. KG at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: COVID-19 pandemic and patient recruitment issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of wound size reduction (time frame: Week 12 post baseline, or last available post-baseline measurement if the Week 12 measurement is missing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02742844.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.

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