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

NCT02742844 | Terminated Phase 1

• 1 other identifier: APZ2-II-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Skin Ulcer Venous Stasis Chronic

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

Outcome Measures

Primary Outcomes (2)

• 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 \[LOCF\])

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

• Assessment of adverse event (AE) occurrence

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

  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)

• Percentage of wound size reduction

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

• Absolute wound size reduction

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

• Proportion of patients achieving complete wound closure

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

• Time to first complete wound closure

  Between baseline and week 12 post baseline

• Proportion of patients achieving 30% wound closure

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

Study Arms (1)

APZ2 application

EXPERIMENTAL

Topical, single application of APZ2; 500000 cells per square cm;

Biological: APZ2 application

Interventions

APZ2 application BIOLOGICAL

Application of IMP on patients wound.

APZ2 application

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• RHEACELL GmbH & Co. KG: lead
• Ticeba GmbH: collaborator
• FGK Clinical Research GmbH: collaborator
• Granzer Regulatory Consulting & Services: collaborator

Study Sites (2)

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

Bochum, 44805, Germany

Location

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Varicose Ulcer; Skin Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andreas Kerstan, PD Dr.med.

  Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Würzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 19, 2016
• Study Start: August 1, 2016
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-02

Locations

DE (2)