Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers
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|ClinicalTrials.gov Identifier: NCT02742844|
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Ulcer Venous Stasis Chronic||Biological: APZ2 application||Phase 1 Phase 2|
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 incorporating the ABCB5+ 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: APZ2 application
Topical, single application of APZ2; 500000 cells per square cm;
Biological: APZ2 application
Application of IMP on patients wound.
- Percentage of wound size reduction [ Time Frame: Week 12 post baseline, or last available post-baseline measurement if the Week 12 measurement is missing ]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])
- Assessment of adverse event (AE) occurrence [ Time Frame: 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 ]All during the clinical trial occurring AEs will be registered, documented and evaluated.
- Percentage of wound size reduction [ Time Frame: Weeks 2, 3, 4, 6, 8, 10 and 12 post baseline ]Percentage of wound size reduction at Weeks 2, 3, 4, 6, 8, 10 and 12 (without LOCF)
- Absolute wound size reduction [ Time Frame: Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline ]
- Proportion of patients achieving complete wound closure [ Time Frame: 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 [ Time Frame: Between baseline and week 12 post baseline ]A priori specification not possible
- Proportion of patients achieving 30% wound closure [ Time Frame: Weeks 2, 3, 4, 6, 8, 10, 12 post baseline ]
- Time to first 30% wound closure [ Time Frame: Between baseline and week 12 post baseline ]A priori specification not possible
- Percentage of wound epithelialization [ Time Frame: At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline ]Amount of wound epithelialization in % of wound area will be assessed by the investigator based on image analysis of images taken from the wound.
- Formation of granulation tissue and wound exudation [ Time Frame: At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline ]
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
- Pain assessment as per numerical rating scale (NRS) [ Time Frame: At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline ]
- Quality of life (QoL) assessment using the SF-36 questionnaire [ Time Frame: At baseline and weeks 4, 8, 12 post baseline ]
- Dermatologic quality of life assessment using the DLQI questionnaire [ Time Frame: At baseline and weeks 4, 8, 12 post baseline ]
- Physical examination and vital parameters [ Time Frame: At Screening, baseline, week 12, month 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742844
|Contact: Christoph Ganss, Dr.||+49 6221 71833 ext firstname.lastname@example.org|
|Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken, Kliniken der Ruhr-Universität Bochum im St. Maria-Hilf-Krankenhaus||Recruiting|
|Bochum, Germany, 44805|
|Principal Investigator: Markus Stücker, Prof.Dr.med.|
|Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Würzburg||Recruiting|
|Würzburg, Germany, 97080|
|Principal Investigator: Andreas Kerstan, PD Dr. med.|
|Principal Investigator:||Andreas Kerstan, PD Dr.med.||Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Würzburg|