The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Peripheral Arterial Occlusive Disease-related clinically relevant ulcers) and safety (by monitoring adverse events) of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive Disease.
This is an interventional, randomised, placebo-controlled, double-blind phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-PAOD for the treatment of Peripheral Arterial Occlusive Disease patients with non-healing ulcers. The allogeneic investigational product allo-APZ2-PAOD contains skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors and stored in a donor cell bank. Patients are followed up for efficacy for 12 weeks by clinical visits at the clinical trial sites to monitor wound healing. The wound healing process of all relevant ulcers will be documented by standardized photography and the quality of the wound healing process will be assessed. Pain will be assessed using a numerical rating scale and quality of life will be investigated with a standardized and validated questionnaire. To assess long-term safety of allo-APZ2-PAOD three follow-up visits at Months 6, 9 and 12 post IMP applications are included. An unblinded external Independent Data Monitoring Committee (IDMC) will continuously monitor safety throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Suspension of ABCB5-positive mesenchymal stem cells in pre-filled syringe
Solution for injection in pre-filled syringe
LKH-Univ. Klinikum Graz
Graz, Austria
Konventhospital der Barmherzigen Brüder Linz
Linz, Austria
Percent change from baseline to week 12 in total wound size of the target leg
Percent change from baseline to week 12 in total wound size of the target leg will be evaluated. The total wound size of the target leg is calculated as sum of the wound sizes of all relevant ulcers of the target leg.
Time frame: Week 12, or last available post-baseline measurement if the Week 12 measurement is missing.
Assessment of adverse event (AE) occurrence
All AEs occurring during the clinical trial will be registered, documented and evaluated.
Time frame: Up to 12 months.
Time to total healing of all relevant ulcers at target leg
Time to total healing of all relevant ulcers at target leg will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline.
Percent change in total wound size of the target leg
Percent change in total wound size of the target leg will be evaluated.
Time frame: Baseline, week 1, 2, 4, 6, and 8.
Absolute change in total wound size of the target leg
Absolute change in total wound size of the target leg will be evaluated.
Time frame: Baseline, week 1, 2, 4, 6, 8 and 12.
Ankle-brachial index (ABI) of target leg;
Ankle-brachial index (ABI) of target leg will be evaluated.
Time frame: Screening Visit, Baseline, Week 2, 4, 8 and 12.
Number of amputated toes at target leg
Number of amputated toes at target leg will be registered, documented and evaluated.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hanusch-Krankenhaus Wien
Vienna, Austria
Krajská zdravotní a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, Czechia
Franziskus-Krankenhaus Berlin
Berlin, Germany
Universitätsklinikum "Carl Gustav Carus" der TU Dresden
Dresden, Germany
Helios Weißeritztal-Kliniken Klinikum Freital
Freital, Germany
Universitäres Herzzentrum Hamburg GmbH (UHZ)
Hamburg, Germany
Asklepios Klinikum Harburg
Hamburg, Germany
St. Josefskrankenhaus Heidelberg GmbH
Heidelberg, Germany
...and 8 more locations
Time frame: A priori specification not possible; between baseline and week 12 post baseline.
Time to major amputation at target leg until week 12;
Time to major amputation at target leg until week 12 will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline.
Assessment of epithelialization in % of wound area of all relevant ulcers of the target leg
Epithelialization of all relevant ulcers of the target leg will be evaluated by the investigator based on image analysis for each ulcer individually.
Time frame: Day 0 prior IMP-application, week 2, 4, 8 and 12.
Assessment of further wound healing parameters: formation of granulation tissue in % of wound area and wound exudation of all relevant ulcers of the target leg
Formation of granulation tissue in % of wound area will be assessed by the investigator based on image analysis for each ulcer individually. Wound exudation of all relevant ulcers of the target leg will be evaluated as high-moderate-low based on amounts of fluid on the wound.
Time frame: Day 0 prior IMP-application, week 2, 4, 8 and 12.
Assessment of quality of life (QoL) using the short form 36 (SF-36) questionnaire
Quality of life (QoL) using the short form 36 (SF-36) questionnaire will be evaluated. The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well being, and overall evaluation of health.
Time frame: Day 0 prior IMP-application, week 2, 8 and 12.
Pain assessment as per numerical rating scale (NRS).
Pain assessment as per numerical rating scale (NRS) will be evaluated.
Time frame: Day 0 prior IMP-application, week 2, 4, 8 and 12.
Physical examination at week 12;
A full physical examination will be performed at week 12 and abnormal physical examination results will be evaluated and reported as AEs.
Time frame: Week 12.
Vital signs: Body temperature at week 12;
Body temperature at week 12 will be evaluated.
Time frame: Week 12.
Vital signs: Blood pressure at week 12;
Blood pressure at week 12 will be evaluated.
Time frame: Week 12.
Vital signs: Heart rate at week 12;
Heart rate at week 12 will be evaluated.
Time frame: Week 12.
Assessment of Laboratory values (Hematology) at Week 12:
The Hematology values will be measured and evaluated at Week 12
Time frame: Week 12.
Assessment of Laboratory values (Clinical chemistry) at Week 12
The clinical chemistry values will be measured and evaluated at Week 12.
Time frame: Week 12.
Time to major amputation
Time to major amputation will be evaluated.
Time frame: A priori specification not possible; between baseline and month 12 post baseline.