The aim of this clinical trial is to investigate the efficacy (by monitoring the wound surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of two doses of the allogeneic investigational medicinal product "allo-APZ2-DFU" topically administered to the wound matrix of patients with diabetic neuropathic ulcer.
This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in patients with diabetic neuropathic ulcer. Allogeneic MSCs will be isolated ex vivo and will be expanded in vitro. The Investigational medicinal product (IMP) containing the ABCB5-positive MSCs will then be applied two times (at Visit 3 and six weeks later, at Visit 10) on the wound surface of DFU. Patients are followed up for efficacy for a period of three months starting after the first IMP application which allows to distinguish actual wound healing from transient wound coverage. The wound healing process will be documented by standardized photography. The wound size reduction evaluation will start two weeks after the first IMP application. 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 allo-APZ2-DFU three follow-up visits at Months 6, 9 and 12 after the first IMP application are included.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Suspension of ABCB5-positive mesenchymal stem cells
Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten
Greifswald, Germany
St. Josefskrankenhaus Heidelberg GmbH; Klinische Studienabteilung
Heidelberg, Germany
Diabetologikum Raab, Privatärztliche Facharztpraxis
Kassel, Germany
pro scientia med im Mare Klinikum, Department Klinische Forschung und Entwicklung
Percentage of wound surface area reduction
Percentage of wound surface area reduction at Week 12, or last available post-baseline measurement of weeks 4, 6 or 8, if the Week 12 measurement is missing (last observation carried forward \[LOCF\]).
Time frame: Week 12, or last available post-baseline measurement of weeks 4, 6 or 8 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
Percentage of wound surface area reduction
Percentage of wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Percentage of invisible and visible wound surface area reduction
Percentage of invisible and visible wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Absolute wound surface area reduction
Absolute wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Absolute invisible and visible wound surface area reduction
Absolute invisible and visible wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Assessment of wound infection
Wound infection will be evaluated.
Time frame: Days 1 and 2, Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kronshagen, Germany
Studienambulanz Leipzig, medamed GmbH
Leipzig, Germany
Diabetologikum Ludwigshafen, Gemeinschaftspraxis
Ludwigshafen, Germany
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg
Würzburg, Germany
Time to first complete wound closure
Time to first complete wound closure will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline
Proportion of patients achieving complete wound closure
Proportion of patients achieving complete wound closure will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12
Time to first 30% reduction of wound surface area
Time to first 30% reduction of wound surface area will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline
Proportion of patients achieving 30% reduction of wound surface area
Proportion of patients achieving 30% reduction of wound surface area will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12
Assessment of wound exudation, epithelialization and formation of granulation tissue
Wound exudation, epithelialization and formation of granulation tissue will be evaluated.
Time frame: Day 0 and Week 6.1 prior IMP-application, at Weeks 1, 2, 4, 6, 8 and 12
Time to amputation at target leg until Week 12
Time to amputation at target leg until week 12 will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline
Pain assessment as per numerical rating scale (NRS)
Pain assessment as per numerical rating scale (NRS) will be evaluated.
Time frame: At both Screening Visits, at Days 0, 1 and 2 and at Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 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.
Time frame: Screening Visit 1, Visit 3, at Weeks 4 and 12
Assessment of Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire
Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire will be evaluated.
Time frame: Screening Visit 1, Visit 3, at Weeks 4 and 12
Physical examination and vital signs
Physical examination and vital signs will be evaluated.
Time frame: Week 6.1 and Week 12
Time to amputation of target leg until month 12
Time to amputation of target leg until month 12 will be evaluated.
Time frame: A priori specification not possible; between baseline and month 12 post baseline