Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)

NCT04971161 | Completed Phase 2 DMC

• 4 other identifiers: allo-APZ2-CVU-IIb2023-510162-27-00U1111-1301-65962020-004960-24
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 38

Brief Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events \[AEs\]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to placebo.

Conditions

Skin Ulcer Venous Stasis Chronic

Keywords

Chronic Venous Ulcer; ABCB5; Allogeneic; Dermal mesenchymal stromal cells; varicose ulcer; skin ulcer; advanced therapy medicinal product; somatic cell therapy; phase IIb

Outcome Measures

Primary Outcomes (2)

• Complete wound closure at Week 18 already persisting for at least two weeks

  Complete wound closure at Week 18 already persisting for at least two weeks will be evaluated.

  Week 18

• Assessment of adverse event (AE) occurrence

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

  Up to 10 months

Secondary Outcomes (11)

• Wound size change in percent at each post-baseline follow-up visit

  Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10

• Time to complete wound closure

  Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10

• Complete wound closures at each post-baseline follow-up visit

  Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16

• Duration of wound closure

  Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10

• Recurrence of the wound

  Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16

Study Arms (4)

allo-APZ2-CVU (dose group 1: 1 x 10e6 cells/cm²)

EXPERIMENTAL

Application of IMP on patients wound

Biological: allo-APZ2-CVU

Placebo

PLACEBO COMPARATOR

Application of IMP on patients wound

Drug: Placebo

allo-APZ2-CVU (dose group 2: 3 x 10e6 cells/cm²)

EXPERIMENTAL

Application of IMP on patients wound

Biological: allo-APZ2-CVU

allo-APZ2-CVU (dose group 3: 6 x 10e6 cells/cm²)

EXPERIMENTAL

Application of IMP on patients wound

Biological: allo-APZ2-CVU

Interventions

allo-APZ2-CVU BIOLOGICAL

Suspension of ABCB5-positive dermal mesenchymal stromal cells. One topical application with a syringe.

Also known as: Skin-derived ABCB5-positive dermal mesenchymal stromal cells

allo-APZ2-CVU (dose group 1: 1 x 10e6 cells/cm²); allo-APZ2-CVU (dose group 2: 3 x 10e6 cells/cm²); allo-APZ2-CVU (dose group 3: 6 x 10e6 cells/cm²)

Placebo DRUG

One topical application with a syringe

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female patients at least 18 years old;
• Chronic venous leg ulcer (as defined by the current AWMF guidelines: therapy-resistant ulcer that shows no tendency to heal within 3 months despite of optimal phlebological therapies or has not fully healed within 12 months) at lower leg and/or ankle region and has not been present longer than 15 years, diagnosed by doppler or duplex sonography, ankle brachial index (ABI, 0.9-1.3), physical examination and dermatological review;
• Wound size of target ulcer between 1 and 50 cm² measured by a standardized photography at the screening visit;
• If patients have 2 or more ulcers at the same extremity, the target ulcer has to be separated by a minimum bridge of 1 cm of epithelialized skin from other ulcers (the largest ulcer should be the target ulcer, if not decided otherwise at discretion of the investigator; the target ulcer is defined at Visit 1);
• Body mass index between 15 and 50 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 Visit 1;
• 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;
• Diabetes mellitus that has to be confirmed by blood test (Hemoglobin A1c \>7.5%);
• Peripheral Artery Disease 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;
• All diagnosed disorders, unrelated to CVU, that are influencing wound healing of the target wound at investigator's discretion;
• Current use of medications that influence wound healing: systemic immunosuppressives, cytotoxic medicinal products, and systemic steroids (above Cushing-threshold level);
• Patient who, in the opinion of the investigator, for any reason are unable or unwilling to complete the trial per protocol (e.g. alcohol or substance abuse, not mobile, short life expectancy) or there is evidence of any other medical condition (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;
• Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases;
• Pregnant or lactating women;
• Any known allergies to components of the IMP;
• Prior surgical procedures such as bypass or mesh-graft treatment at target leg within 2 months prior to Visit 1 at target leg;
• Patients with significant ulcer healing or wound size enlargement of more than 25% at Visit 2 compared to Visit 1;
• Treatment of target ulcer with active wound care agents (e.g. Iruxol®N), which have not been paused 14 days before IMP application;

Sponsors & Collaborators

• RHEACELL GmbH & Co. KG: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (38)

MVZ Gefäßzentrum Aachen am Marienhospital Aachen GmbH

Aachen, 52066, Germany

Location

Universitätsklinikum Augsburg, Klinik für Dermatologie und Allergologie, Campus Süd

Augsburg, 86179, Germany

Location

Fachklinik Bad Bentheim, Dermatologische Ambulanz

Bad Bentheim, 48455, Germany

Location

Helios Klinikum Berlin-Buch, Klinik für Plastische und Ästhetische Chirurgie

Berlin, 13125, Germany

Location

Helios Klinikum Emil von Behring, Klinik für Plastische und Ästhetische Chirurgie

Berlin, 14165, Germany

Location

Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus, Hautzentrum im Jahrhunderthaus

Bochum, 44793, Germany

Location

Katholisches Klinikum Bochum gGmbH, Venenzentrum der Kliniken für Dermatologie und Gefäßchirurgie der Ruhr-Universität Bochum

Bochum, 44805, Germany

Location

Hautärzte Braunschweig am Altstadtmarkt, Hautärztliche Gemeinschaftspraxis

Braunschweig, 38100, Germany

Location

Klinikum Bremerhaven Reinkenheide gGmbH, Klinik für Dermatologie, Allergologie und Phlebologie, Wundzentrum

Bremerhaven, 27574, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Universitätsklinikum Erlangen, Hautklinik - Wundzentrum Dermatologie

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Essen, 45147, Germany

Location

Universitätsklinikum Freiburg, Klinik für Dermatologie und Venerologie

Freiburg im Breisgau, 79104, Germany

Location

Marienhospital Gelsenkirchen GmbH, Klinik für Chirurgie (Allgemein-, Viszeral- und Endokrine Chirurgie, Thorax-, Gefäß- und Endovaskuläre Chirurgie und Kinderchirurgie)

Gelsenkirchen, 45886, Germany

Location

SRH Wald-Klinikum Gera GmbH, Zentrum für Klinische Studien

Gera, 07548, Germany

Location

Universitätsmedizin Greifswald, Klinik und Poliklinik für Hautkrankheiten

Greifswald, 17475, Germany

Location

Praxis Dr. med. Abdou Zarzour

Halle, 06108, Germany

Location

Universitätsklinikum Hamburg- Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

Hamburg, 20246, Germany

Location

MVZ Prof. Dr. Ockenfels, Haut und Allergie-Praxisklinik GmbH

Hanau, 63450, Germany

Location

Klinikum Region Hannover GmbH, KRH Klinikum Siloah, Klinik für Nephrologie, Angiologie und Rheumatologie

Hanover, 30459, Germany

Location

Zentrum für Dermatochirurgie, St. Josefskrankenhaus Heidelberg GmbH

Heidelberg, 69115, Germany

Location

SRH Klinikum Karlsbad- Langensteinbach GmbH, Interdisziplinäres Gefäßzentrum Innere Medizin

Karlsbad, 76307, Germany

Location

Medizinisches Versorgungszentrum DermaKiel GmbH

Kiel, 24148, Germany

Location

Hautarztpraxis Langenau, Studienzentrum

Langenau, 89129, Germany

Location

Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Leipzig, 04103, Germany

Location

Diabetologikum Ludwigshafen, die Praxis am Ludwigsplatz

Ludwigshafen, 67059, Germany

Location

Beldio Research GmbH

Memmingen, 87700, Germany

Location

Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie

München, 80337, Germany

Location

Universitätsklinikum Münster, Klinik für Hautkrankheiten, Allgemeine Dermatologie und Venerologie

Münster, 48149, Germany

Location

Klinikum Nürnberg Nord, Klinik für Dermatologie

Nuremberg, 90419, Germany

Location

MVZ Corius Potsdam GmbH, Dermatologie Potsdam MVZ

Potsdam, 14467, Germany

Location

Caritas-Krankenhaus St. Josef, Klinik für Plastische und Ästhetische, Hand- und Wiederherstellungschirurgie

Regensburg, 93053, Germany

Location

Universitätsmedizin Rostock, Klinik und Poliklinik für Dermatologie und Venerologie

Rostock, 18057, Germany

Location

Helios Kliniken Schwerin, Plastische, Rekonstruktive und Ästhetische Chirurgie

Schwerin, 19049, Germany

Location

Hautärztliche Gemeinschaftspraxis Dr. Leitz und Kollegen

Stuttgart, 70178, Germany

Location

Universitätsklinikum Tübingen, Universitäts-Hautklinik Tübingen

Tübingen, 72076, Germany

Location

Helios Universitätsklinikum Wuppertal, Zentrums für Dermatologie, Allergologie und Dermatochirurgie

Wuppertal, 42283, Germany

Location

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

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, Dr.

  Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind, dose-ranging, interventional, multicenter, phase IIb clinical trial

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 21, 2021
• Study Start: August 18, 2021
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (38)