Venous Leg UlcerPhase 3NCT06489028
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
A Phase 3 study testing allo-APZ2-CVU in people with Venous Leg Ulcer, run by RHEACELL GmbH & Co. KG at 15 sites in 12 countries.
Trial summary
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- allo-APZ2-CVU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 15 sitesin 12 countries
- Study dates
- 26 Dec 2024to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old;
- Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler or Duplex sonography, ankle brachial index, physical examination and dermatological review;
- Wound size at V1 and V2 between 1 and 25 cm˄2 as measured by standardized photography;
- If patients have 2 or more ulcers at the same extremity, the target ulcer has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide;
- Body mass index between 15 and 50 kg/m²;
- Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures;
- Women of childbearing potential must have a negative urine pregnancy test at Visit 1;
- 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.
Who cannot join
- Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
- Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test);
- Peripheral Artery Disease including claudication with need of treatment or intervention;
- Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis;
- Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1;
- 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;
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- Acute wound infection of ulcer requiring treatment as judged clinically;
- Current use of medications that are known to influence wound healing i.e. systemic immunosuppressives, cytotoxic medicinal products, systemic steroids (above Cushingthreshold level) at investigator´s discretion;
- 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;
- 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;
- Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo;
- Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1;
- Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase;
- Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion);
- Employees of the sponsor, or employees or relatives of the investigator(s).
Trial locations and contacts
15 sites in 12 countries.
15 sites in 12 countries
United States4 sites
RHEACELL Clinical Trial Site
Boston, Massachusetts, 02114
RHEACELL Clinical Trial Site
Hialeah, Florida, 33012
RHEACELL Clinical Trial Site
Miami, Florida, 33136
RHEACELL Clinical Trial Site
Minneapolis, Minnesota, 55455
About this study
Official title: A Pivotal, Randomized, Placebo-controlled, Double-blind, Multicenter, International Phase III Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Non-Healing Chronic Venous Ulcers (CVU)
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
Read the detailed description
This is a pivotal, randomized, placebo-controlled, double-blind, multicenter, international phase III clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant non-healing CVU.
The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank.
Patients will be randomized to be treated with allo-APZ2-CVU or placebo. The patients will undergo treatment with the IMP on Day 0 (V3) and will be followed up for efficacy for 18 weeks (V4 until V14). Three safety follow-up visits will be performed at Month 6 (V15), Month 10 (V16) and Month 16 (V17).
The wound healing process will be documented by standardized photography.
The wound size measurement will start at the first Screening Visit (V1) and will be measured at each following on-site visit.
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires.
- Conditions
- Venous Leg Ulcer
- Being tested
- allo-APZ2-CVU, Placebo
- Keywords
- Chronic Venous Ulcer, ABCB5, Allogeneic, Dermal mesenchymal stromal cells, varicose ulcer, skin ulcer, advanced therapy medicinal product, somatic cell therapy, phase III
- Medical subject headings
- Varicose Ulcer, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allo-APZ2-CVUDrug
Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Not described Receives: Drug: allo-APZ2-CVU |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure
Complete wound closure already persisting for at least two weeks
Measured: 18 weeks
Secondary outcomes (1)
Complete wound closures at each post-baseline follow-up visit
Complete wound closures at each post-baseline follow-up visit
Measured: at each post-baseline follow-up visit (starting the day after intervention until month 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start26 Dec 2024
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RHEACELL GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Anna Moessmer, Study director, RHEACELL GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489028
- Sponsor's protocol ID
- allo-APZ2-CVU-III
- Other IDs
- 2024-512720-11-00, U1111-1305-5114
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Randomized, Placebo-controlled, Double-blind, Multicenter, International Phase III Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Non-Healing Chronic Venous Ulcers (CVU)
- ClinicalTrials.gov ID
- NCT06489028
- Acronym / sponsor ID
- allo-APZ2-CVU-III
- Conditions
- Venous Leg Ulcer
- Keywords
- Chronic Venous Ulcer, ABCB5, Allogeneic, Dermal mesenchymal stromal cells, varicose ulcer, skin ulcer, advanced therapy medicinal product, somatic cell therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- RHEACELL GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
Detailed description
This is a pivotal, randomized, placebo-controlled, double-blind, multicenter, international phase III clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant non-healing CVU.
The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank.
Patients will be randomized to be treated with allo-APZ2-CVU or placebo. The patients will undergo treatment with the IMP on Day 0 (V3) and will be followed up for efficacy for 18 weeks (V4 until V14). Three safety follow-up visits will be performed at Month 6 (V15), Month 10 (V16) and Month 16 (V17).
The wound healing process will be documented by standardized photography.
The wound size measurement will start at the first Screening Visit (V1) and will be measured at each following on-site visit.
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: allo-APZ2-CVU |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients at least 18 years old;
- Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler or Duplex sonography, ankle brachial index, physical examination and dermatological review;
- Wound size at V1 and V2 between 1 and 25 cm˄2 as measured by standardized photography;
- If patients have 2 or more ulcers at the same extremity, the target ulcer has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide;
- Body mass index between 15 and 50 kg/m²;
Key exclusion criteria (16 listed)
- Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
- Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test);
- Peripheral Artery Disease including claudication with need of treatment or intervention;
- Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis;
- Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allo-APZ2-CVUAllogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs) | Drug | Verum |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Complete wound closure
Time frame: 18 weeks
Complete wound closure already persisting for at least two weeks
1 secondary outcome
Complete wound closures at each post-baseline follow-up visit
Time frame: at each post-baseline follow-up visit (starting the day after intervention until month 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Moessmer study director
RHEACELL GmbH & Co. KG
15 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing allo-APZ2-CVU in people with Venous Leg Ulcer, run by RHEACELL GmbH & Co. KG at 15 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Austria, Czechia, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.