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Could skin cells heal stubborn leg wounds? new trial tests a One-Time treatment

NCT ID NCT04971161

Disease control Sponsor: RHEACELL GmbH & Co. KG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2b trial tested a one-time application of a cell therapy made from donor skin cells (Allo-APZ2-CVU) in 159 people with chronic venous leg ulcers that hadn't healed despite standard care. The goal was to see if it could shrink or close these wounds better than a placebo, and to check for side effects. Results will show whether this approach is worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Skin-derived ABCB5-positive dermal mesenchymal stromal cells (Allo-APZ2-CVU)
What this could lead to
If successful, this could offer a new treatment option for people with chronic venous ulcers that don't heal with standard care.
What could go wrong
This is a mid-stage trial with only 159 participants, so results may not apply to everyone. The treatment is applied once, and it's unclear if effects last long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

159 people

The number who actually took part.

Started

Aug 2021

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients at least 18 years old; 2. 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; 3. Wound size of target ulcer between 1 and 50 cm² measured by a standardized photography at the screening visit; 4. 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); 5. Body mass index between 15 and 50 kg/m²; 6. Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure; 7. Women of childbearing potential must have a negative blood pregnancy test at Visit 1; 8. Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial. Exclusion Criteria: 1. Evidence of the ulcer extending to the underlying muscle, tendon, or bone; 2. Diabetes mellitus that has to be confirmed by blood test (Hemoglobin A1c \>7.5%); 3. Peripheral Artery Disease including claudication with need of treatment; 4. Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep vein thrombosis; 5. Unable to tolerate leg ulcer compression bandage; 6. Infection of the target ulcer requiring treatment as judged clinically; 7. All diagnosed disorders, unrelated to CVU, that are influencing wound healing of the target wound at investigator's discretion; 8. Current use of medications that influence wound healing: systemic immunosuppressives, cytotoxic medicinal products, and systemic steroids (above Cushing-threshold level); 9. 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; 10. 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; 11. Pregnant or lactating women; 12. Any known allergies to components of the IMP; 13. Prior surgical procedures such as bypass or mesh-graft treatment at target leg within 2 months prior to Visit 1 at target leg; 14. Patients with significant ulcer healing or wound size enlargement of more than 25% at Visit 2 compared to Visit 1; 15. Treatment of target ulcer with active wound care agents (e.g. Iruxol®N), which have not been paused 14 days before IMP application; 16. Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial; 17. Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion); 18. Employees of the sponsor, or employees or relatives of the investigator.

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Conditions

The condition(s) this trial relates to.

chronic ulcer of skin Skin Ulcer Varicose Ulcer venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Skin ulcer venous stasis chronic

Contacts and locations

Locations

  • Beldio Research GmbH

    Memmingen, 87700, Germany

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

    Regensburg, 93053, Germany

  • Diabetologikum Ludwigshafen, die Praxis am Ludwigsplatz

    Ludwigshafen, 67059, Germany

  • Fachklinik Bad Bentheim, Dermatologische Ambulanz

    Bad Bentheim, 48455, Germany

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

    Bochum, 44793, Germany

  • Hautarztpraxis Langenau, Studienzentrum

    Langenau, 89129, Germany

  • Hautärzte Braunschweig am Altstadtmarkt, Hautärztliche Gemeinschaftspraxis

    Braunschweig, 38100, Germany

  • Hautärztliche Gemeinschaftspraxis Dr. Leitz und Kollegen

    Stuttgart, 70178, Germany

  • Helios Kliniken Schwerin, Plastische, Rekonstruktive und Ästhetische Chirurgie

    Schwerin, 19049, Germany

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

    Berlin, 13125, Germany

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

    Berlin, 14165, Germany

  • Helios Universitätsklinikum Wuppertal, Zentrums für Dermatologie, Allergologie und Dermatochirurgie

    Wuppertal, 42283, Germany

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

    Bochum, 44805, Germany

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

    Bremerhaven, 27574, Germany

  • Klinikum Nürnberg Nord, Klinik für Dermatologie

    Nuremberg, 90419, Germany

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

    Hanover, 30459, Germany

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

    München, 80337, Germany

  • Klinische Forschung Dresden GmbH

    Dresden, 01069, Germany

  • MVZ Corius Potsdam GmbH, Dermatologie Potsdam MVZ

    Potsdam, 14467, Germany

  • MVZ Gefäßzentrum Aachen am Marienhospital Aachen GmbH

    Aachen, 52066, Germany

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

    Hanau, 63450, Germany

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

    Gelsenkirchen, 45886, Germany

  • Medizinisches Versorgungszentrum DermaKiel GmbH

    Kiel, 24148, Germany

  • Praxis Dr. med. Abdou Zarzour

    Halle, 06108, Germany

  • SRH Klinikum Karlsbad- Langensteinbach GmbH, Interdisziplinäres Gefäßzentrum Innere Medizin

    Karlsbad, 76307, Germany

  • SRH Wald-Klinikum Gera GmbH, Zentrum für Klinische Studien

    Gera, 07548, Germany

  • Universitätsklinikum Augsburg, Klinik für Dermatologie und Allergologie, Campus Süd

    Augsburg, 86179, Germany

  • Universitätsklinikum Erlangen, Hautklinik - Wundzentrum Dermatologie

    Erlangen, 91054, Germany

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

    Essen, 45147, Germany

  • Universitätsklinikum Freiburg, Klinik für Dermatologie und Venerologie

    Freiburg im Breisgau, 79104, Germany

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

    Hamburg, 20246, Germany

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

    Leipzig, 04103, Germany

  • Universitätsklinikum Münster, Klinik für Hautkrankheiten, Allgemeine Dermatologie und Venerologie

    Münster, 48149, Germany

  • Universitätsklinikum Tübingen, Universitäts-Hautklinik Tübingen

    Tübingen, 72076, Germany

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

    Würzburg, 97080, Germany

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Hautkrankheiten

    Greifswald, 17475, Germany

  • Universitätsmedizin Rostock, Klinik und Poliklinik für Dermatologie und Venerologie

    Rostock, 18057, Germany

  • Zentrum für Dermatochirurgie, St. Josefskrankenhaus Heidelberg GmbH

    Heidelberg, 69115, Germany