Clinical trial • Phase III • Dermatology

Allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells for Chronic venous leg ulcer

Phase III trial of Allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells for Chronic venous leg ulcer.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Chronic venous leg ulcer
Trial Stage
Phase III
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
16-12-2024

Trial design

Randomised, placebo: topical application of a single dose of placebo on the wound surface of selected cvu on day 0; ip: allo-apz2-cvu (investigational product) topical single dose of 1 x 10^6 cells/cm^2 applied on the wound surface of selected cvu on day 0.-controlled Phase III trial in Germany, Hungary, Poland and others.

Randomised
Yes
Comparator
Placebo: topical application of a single dose of Placebo on the wound surface of selected CVU on Day 0; IP: allo-APZ2-CVU (investigational product) topical single dose of 1 x 10^6 cells/cm^2 applied on the wound surface of selected CVU on Day 0.
Target Sample Size
250
Trial Duration For Participant
522

Eligibility

Recruits 250 Vulnerable population flag selected. Participants must be adults (≥18 years) and "Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures"; consent must be provided in writing by the participant. No procedures for assent or enrolment of minors are described..

Pregnancy Exclusion
Pregnant or lactating women
Vulnerable Population
Vulnerable population flag selected. Participants must be adults (≥18 years) and "Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures"; consent must be provided in writing by the participant. No procedures for assent or enrolment of minors are described.

Inclusion criteria

  • {"criterion_text":"- Patients at least 18 years old\n- Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler-Duplex sonography, ankle brachial index (ABI, 0.9-1.3; optionally, in case ABI > 1.3 or not measurable: toe brachial index (TBI) ≥0.7)), physical examination and dermatological review\n- Wound size at V1 and V2 between 1 and 25 cm2 as measured by standardized photography\n- If patients have 2 or more ulcers at the same extremity, the target ulcer (defined at V2) has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide\n- Body mass index between 15 and 50 kg/m²\n- Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures\n- Women of childbearing potential must have a negative urine pregnancy test at Visit 1\n- During the course of the clinical trial women of childbearing potential and their male partners must be willing to use highly effective contraceptive methods as defined in the EMA CTCG “Recommendations related to contraception and pregnancy testing in clinical trials\", Version 1.2."}

Exclusion criteria

  • {"criterion_text":"- Evidence of the ulcer extending to the underlying muscle, tendon, or bone\n- 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\n- Pregnant or lactating women\n- Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo\n- Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1\n- Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase\n- Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion)\n- Employees of the sponsor, or employees or relatives of the investigator(s)\n- Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test)\n- Peripheral Artery Disease including claudication with need of treatment or intervention\n- Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis\n- Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1\n- Patients with known hypersensitivity and/or clinical contraindications to the compression systems used in the clinical trial, or inability/unwillingness to tolerate leg ulcer compression systems\n- Acute wound infection of ulcer requiring treatment as judged clinically\n- Current use of medications that are known to influence wound healing i.e. systemic immunosuppressives, cytotoxic medicinal products, systemic steroids (above Cushing-threshold level) at investigator´s discretion\n- Patients 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 an 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy: Complete wound closure at Week 18 already persisting for at least two weeks","definition_or_measurement_approach":"Complete wound closure assessed at Week 18 and required to have persisted for at least two weeks; wound measurements use standardized photography."}
  • {"endpoint_text":"- Safety: Adverse events","definition_or_measurement_approach":"Safety assessed by monitoring and recording adverse events (AEs) throughout the trial per standard AE reporting procedures."}

Secondary endpoints

  • {"endpoint_text":"- Complete wound closures at each post-baseline follow-up visit","definition_or_measurement_approach":"Assessed at each post-baseline follow-up visit using standardized wound assessments/photography."}
  • {"endpoint_text":"- Wound size change in percent at each post-baseline follow-up visit","definition_or_measurement_approach":"Percent change in wound area measured at each post-baseline visit (standardized photography measurement)."}
  • {"endpoint_text":"- Quality of wound healing at each post-baseline follow-up visit","definition_or_measurement_approach":"Qualitative assessment of wound healing documented at each follow-up visit."}
  • {"endpoint_text":"- Assessment of Quality of Life using the Wound-Quality of Life Questionnaire (W-QoL) as well as the EQ-5D-5L Questionnaire and the SF-36 at V8, V11, V14, V15, V16, V17","definition_or_measurement_approach":"Quality of life measured using W-QoL, EQ-5D-5L and SF-36 questionnaires at specified visits V8, V11, V14, V15, V16, V17."}
  • {"endpoint_text":"- Pain assessment as per numerical rating scale (NRS) on each post-baseline follow-up visit","definition_or_measurement_approach":"Patient-reported pain measured using the Numerical Rating Scale (NRS) at each follow-up visit."}
  • {"endpoint_text":"- Duration of wound closure","definition_or_measurement_approach":"Time period that a wound remains closed, recorded per follow-up visits."}
  • {"endpoint_text":"- Recurrence of the wound","definition_or_measurement_approach":"Occurrence of wound recurrence recorded during follow-up visits."}
  • {"endpoint_text":"- Time to complete wound closure","definition_or_measurement_approach":"Time from IP application (Day 0) to confirmed complete wound closure."}
  • {"endpoint_text":"- Physical examination and vital signs at V14","definition_or_measurement_approach":"Physical exam and vital signs assessments performed at visit V14."}
  • {"endpoint_text":"- Assessment of immunogenicity","definition_or_measurement_approach":"Immunogenicity assessments (e.g. anti-HLA antibody levels and other assays) as specified in protocol."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
250
Recruitment Window Months
31
Consent Approach
Informed consent is obtained in writing from each participant (participants must be ≥18 years and able to understand the study). Subject information sheets and ICF documents are prepared per country/language (country-specific SIS and ICF files listed for AUT, DEU, FRA, HUN, ITA, NLD, POL, CZE, SVK, SWE), with participants providing written consent prior to any trial procedures. No assent process for minors is described (minors are excluded).

Methods

  • Patient Recruitment Service (Trials24 GmbH) providing patient recruitment in AUT, DEU, CZE, HUN, ITA, NLD, POL (country-specific contracted recruitment).
  • Site-level materials: doctors' letters, patient letters, leaflets, checklists and site flyers/posters distributed at sites (country-specific versions present for HUN, POL, CZE, AUT, NLD, ITA, DEU, SWE, SVK, FRA).
  • Digital recruitment / online advertising: landing pages, web/print banners, online pre-screening questions and online advertising materials (explicitly present for Germany site Dresden, Sweden, Slovakia and Netherlands materials).
  • Local newspaper advertisement (Germany) and other local media as site-specific recruitment material.

Geography

Total Number Of Sites
57
Total Number Of Participants
156

Germany

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
581
Number Of Sites
16
Number Of Participants
40

Sites

Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
n.a.
Contact Person Name
Daniel Schiltz
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik für Nephrologie, Angiologie und Rheumatologie
Contact Person Name
Jan Menne
Contact Person Email
nephrologie.siloah@krh.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Hautkrankheiten
Contact Person Name
Stine Lutze
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik, Wundzentrum Dermatologie
Contact Person Name
Cornelia Erfurt-Berge
Site Name
Universitätsklinikum Essen
Department Name
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Joachim Dissemond
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Gefäßchirurgie
Contact Person Name
Bernhard Dorweiler
Contact Person Email
vascularstudy@uk-koeln-de
Site Name
Praxis Dr. med. Abdou Zarzour
Department Name
n.a.
Contact Person Name
Abdou Zarzour
Contact Person Email
info@hautarzthalle.de
Site Name
Rostock University Medical Center
Department Name
Klinik und Poliklinik für Dermatologie und Venerologie
Contact Person Name
Susen Rode
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Zentrum für Dermatologie, Allergologie und Dermatochirurgie
Contact Person Name
Silke Hofmann
Contact Person Email
wup-derma@helios-gesundheit.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Kerstan
Contact Person Email
a.kerstan@ukw.de
Site Name
Ruhr-Universität Bochum
Department Name
Venenzentrum der Kliniken für Dermatologie und Gefäßchirurgie
Contact Person Name
Markus Stücker
Site Name
Klinische Forschung Dresden GmbH
Department Name
n.a.
Contact Person Name
Peter Heymer
Contact Person Email
info-dresden@pratia.com
Site Name
Klinikum Bremerhaven-Reinkenheide gGmbH
Department Name
Klinik für Dermatologie, Allergologie und Phlebologie, Wundzentrum
Contact Person Name
Michael Max Sachse
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Zentrum für klinische Studien
Contact Person Name
Sabine Sell
Contact Person Email
studienzentrum.wkg@srh.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Hautklinik
Contact Person Name
Anke Strölin
Site Name
MVZ Prof. Dr. Ockenfels Haut- und Allergie-Praxisklinik GmbH
Department Name
n.a.
Contact Person Name
Michael Ockenfels
Contact Person Email
info@hautklinik-hanau.de

Hungary

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
14-10-2025
Processing Time Days
426
Number Of Sites
11
Number Of Participants
36

Sites

Site Name
University Of Pecs
Department Name
Általános Orvostudományi Kar, Bőr-, Nemikórtani és Onkodermatológiai Klinika
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
hilbert.helga@pte.hu
Site Name
Derma-B Kft.
Department Name
n.a.
Contact Person Name
Emese Herédi
Contact Person Email
info@dririnyi.hu
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
n.a.
Contact Person Name
Zoltan Sallo
Contact Person Email
infos@clinexpert.hu
Site Name
University Of Debrecen
Department Name
Bőrgyógyászati Klinika
Contact Person Name
Evá Szabó
Contact Person Email
bik@med.unideb.hu
Site Name
Obudai Egeszseguegyi Centrum Kft. (Budapest III)
Department Name
n.a.
Contact Person Name
Beáta Bakos
Contact Person Email
gabor.kiss@oecresearch.com
Site Name
Obudai Egeszseguegyi Centrum Kft. (Kaposvar)
Department Name
n.a.
Contact Person Name
Andrea Várkonyi
Contact Person Email
gabor.kiss@oecresearch.com
Site Name
Obudai Egeszseguegyi Centrum Kft. (Zalaegerszeg)
Department Name
n.a.
Contact Person Name
Marianna Bába
Contact Person Email
gabor.kiss@oecresearch.com
Site Name
Clinexpert Kft.
Department Name
n.a.
Contact Person Name
Zoltán Kökény
Contact Person Email
info@clinexpert.hu
Site Name
Obudai Egeszseguegyi Centrum Kft. (Dunaujvaros)
Department Name
n.a.
Contact Person Name
Péter Dános
Contact Person Email
gabor.kiss@oecresearch.com
Site Name
BKS Research Kft.
Department Name
n.a.
Contact Person Name
Zsuzsanna Varga
Contact Person Email
gergely.beldi@bksresearch.hu
Site Name
Semmelweis University
Department Name
Általános Orvostudományi Kar, Bőr-, Nemikórtani és Bőronkológiai Klinika
Contact Person Name
Péter Holló
Contact Person Email
klinikaikutatas@semmelweis.hu

Poland

Earliest CTIS Part Ii Submission Date
04-09-2024
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
406
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Clinicmed Daniluk Nowak Sp. k.
Department Name
n.a.
Contact Person Name
Nonna Anna Nowak
Contact Person Email
lipska@clinicmed.pl
Site Name
Mikomed Sp. z o.o.
Department Name
n.a.
Contact Person Name
Jacek Mikosiński
Contact Person Email
mikomed@mikomed.pl
Site Name
Pracownia Badan Klinicznych Salus
Department Name
n.a.
Contact Person Name
Maciej Rabczyński
Contact Person Email
magdalena.golabek@pbks.com.pl
Site Name
ARGO Centrum Medyczne sp z o.o.
Department Name
n.a.
Contact Person Name
Przemysław Lipiński
Contact Person Email
badaniakliniczne@argo-med.pl
Site Name
Centrum Medyczne Ultramed
Department Name
n.a.
Contact Person Name
Mikołaj Maga
Contact Person Email
biuro@ultramed-krakow.pl
Site Name
Podos Klinika Leczenia Ran sp. z o.o.
Department Name
n.a.
Contact Person Name
Arkadiusz Krakowiecki
Contact Person Email
akrakus@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
416
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Cévní chirurgie UL s.r.o.
Department Name
n.a.
Contact Person Name
Martin Sauer
Contact Person Email
phlebo-sun@seznam.cz
Site Name
Kožní ambulance Fialová, s.r.o.
Department Name
n.a.
Contact Person Name
Alena Fialová
Contact Person Email
alenka.fialova@seznam.cz
Site Name
CTC Hodonin s.r.o.
Department Name
n.a.
Contact Person Name
Jiří Matuska
Contact Person Email
jiri.matuska@matmed.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Dermatovenerologická klinika
Contact Person Name
Filip Rob
Contact Person Email
karolina.raszykova@bulovka.cz
Site Name
Salvatella s.r.o.
Department Name
n.a.
Contact Person Name
Jan Stryja
Contact Person Email
jan.stryja@atlas.cz
Site Name
Nemocnice Trebic příspěvková organizace
Department Name
n.a.
Contact Person Name
Sandra Bogorová
Contact Person Email
oms@trebichospital-tr.cz

Austria

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
594
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Medical University Of Vienna
Department Name
Division of Angiology
Contact Person Name
Oliver Schlager
Site Name
Medizinische Universität Graz
Department Name
Klinische Abteilung für plastische, ästhetische und rekonstruktive Chirurgie
Contact Person Name
Lars Kamolz
Contact Person Email
arlinda.lushtaku@medunigraz.at

Netherlands

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
565
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Rijnstate Ziekenhuis Stichting
Department Name
n.a.
Contact Person Name
Marjolein Birgitte Visch
Contact Person Email
vascularsurgery@rijnstate.nl

Italy

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
656
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
ASL di Frosinone Centro ulcere cutanee
Department Name
n.a.
Contact Person Name
Alessandro Greco
Site Name
Policlinico Di Monza S.p.A.
Department Name
Clinica Eporediese, Vascular surgery: Vulnology Unit
Contact Person Name
Elia Ricci
Contact Person Email
monicapittarello@hotmail.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Dermatologia, Ospedale S. Chiara
Contact Person Name
Marco Romanelli
Contact Person Email
info.dermopisa@gmail.com
Site Name
Azienda Unita' Sanitaria Locale Toscana Sud Est - U.O.C Chirurgia Generale d‘Urgenza
Department Name
n.a.
Contact Person Name
Cosimo Maglio

Sweden

Earliest CTIS Part Ii Submission Date
05-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
587
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
n.a.
Contact Person Name
Rahime Inci
Contact Person Email
anna-carin.varvne@vregion.se

France

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
568
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
n.a.
Contact Person Name
Philippe Célérier
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Dermatologie
Contact Person Name
Marie Daude
Contact Person Email
marie.daude@chu-nantes.fr
Site Name
Hospices Civils De Lyon (Hôpital Edouard Herriot)
Department Name
Hôpital Edouard HERRIOT
Contact Person Name
Judith Catella
Contact Person Email
Umichon-psturel@ghpsj.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Vascular Medicine
Contact Person Name
Sophie Blaise
Contact Person Email
sblaise@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service Médicine Vasculaire
Contact Person Name
Monria Nou-Howaldt
Contact Person Email
m-nou@chu-montpellier.fr

Slovakia

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
582
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Angiologická ambulancia (Dunajská Streda)
Department Name
n.a.
Contact Person Name
Melinda Malá
Contact Person Email
melinda8mala@gmail.com
Site Name
Angiocomfort s.r.o.
Department Name
n.a.
Contact Person Name
Eva Čenčariková
Contact Person Email
angiocomfort@gmail.com
Site Name
Angiologická ambulancia (Trnava)
Department Name
n.a.
Contact Person Name
Martina Padúchová
Contact Person Email
ambulanciatt@medena.sk
Site Name
Sanare spol. s r.o.
Department Name
n.a.
Contact Person Name
Hana Zelenková
Contact Person Email
zelenkova@vl.sk
Site Name
Venasum s.r.o.
Department Name
n.a.
Contact Person Name
Marek Šumaj
Contact Person Email
marek.sumaj@gmail.com

Sponsor

Primary sponsor

Full Name
Rheacell GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
FGK Clinical Research GmbH
Responsibilities
Multiple trial execution responsibilities (codes listed in sponsor duties: 1,10,11,12,13,5,6,8) - operational/CRO functions
Name
FGK Clinical Research Sp. z o.o.
Responsibilities
Site support/operational duties (codes: 1;12)
Name
FGK Clinical Research Kft.
Responsibilities
Site support/operational duties (codes: 1;12)
Name
FGK Clinical Research s.r.o.
Responsibilities
Site support/operational duties (codes: 1;12)
Name
Invisio Clinical Studies Consulting GmbH
Responsibilities
Site specific duties and support via flying study nurses for home based patient treatment
Name
Trials24 GmbH
Responsibilities
Patient recruitment service in multiple countries
Name
CLINOps Polska
Responsibilities
Logistics – reimbursement of patient travel costs in Poland

Third parties

  • {"country":"Hungary","full_name":"Trialbooster Kft.","duties_or_roles":"Logistics – Reimbursement of patient travel costs in Hungary","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Invisio Clinical Studies Consulting GmbH","duties_or_roles":"Site specific duties and support via flying study nurses for home based patient treatment","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"KasaConsult","duties_or_roles":"Codes: 1; 12","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Probando GmbH","duties_or_roles":"Logistics – Reimbursement of patient travel costs in Italy, Netherlands, Austria, Sweden","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"New Zealand","full_name":"Aranz medical","duties_or_roles":"provision of platform and software for image capture and measurement","organisation_type":"Industry"}
  • {"country":"Poland","full_name":"FGK Clinical Research Sp. z o.o.","duties_or_roles":"Codes: 1; 12","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"Code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Rheacell GmbH & Co. KG","duties_or_roles":"Sample storage and preparation for analyses","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eTMF provider","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Camovis GmbH","duties_or_roles":"Site specific duties and support via flying study nurses for home based patient treatment (Germany only)","organisation_type":"Health care"}
  • {"country":"Germany","full_name":"Trials24 GmbH","duties_or_roles":"Patient Recruitment Service in AUT, DEU, CZE, HUN, ITA, NLD, POL","organisation_type":"Industry"}
  • {"country":"Austria","full_name":"Bender Medsystems GmbH","duties_or_roles":"Analyses of wound exudate and scab","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Hippocrates Research S.r.l.","duties_or_roles":"Codes: 1; 12","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"TrialPEX","duties_or_roles":"Logistics – Reimbursement of patient travel costs in France","organisation_type":"Industry"}
  • {"country":"Czechia","full_name":"FGK Clinical Research s.r.o.","duties_or_roles":"Codes: 1; 12","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Aurevia AB","duties_or_roles":"Codes: 1; 12","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"Flex Databases s.r.o.","duties_or_roles":"CTMS provider, Team training management system","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"FGK Clinical Research GmbH","duties_or_roles":"Codes: 1;10;11;12;13;5;6;8","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"BKS Research Kft.","duties_or_roles":"anti-HLA antibody levels analyses for assessment of immunogenicity","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Hungary","full_name":"FGK Clinical Research Kft.","duties_or_roles":"Codes: 1;12","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"CLINOps Polska","duties_or_roles":"Logistics – Reimbursement of patient travel costs in Poland","organisation_type":"Industry"}

Investigational products

Investigational Product Name
allo-APZ2-CVU
Active Substance
Allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells
Modality
Cell therapy
Routes Of Administration
Cutaneous use (topical)
Route
Topical (cutaneous)
Starting Dose
1 x 10^6 cells/cm^2
Dose Levels
1 x 10^6 cells/cm^2 (single dose)
Frequency
Single dose (Day 0)
Maximum Dose
25 million organisms (maxTotalDoseAmount 25)
Investigational Product Name
Placebo
Modality
Other
Routes Of Administration
Topical (on wound surface)
Route
Topical (cutaneous)
Starting Dose
single topical application (placebo)
Dose Levels
single application
Frequency
Single dose (Day 0)

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