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Using skin-derived cells to treat stubborn venous leg ulcers

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)

Phase 3 Interventional RHEACELL GmbH & Co. KG · NCT06489028

This study is testing a new treatment using skin cells to see if it can help people with stubborn leg ulcers that haven't healed with other methods.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorRHEACELL GmbH & Co. KG Industry-sponsored
Locations16 sites (Hialeah, Florida and 15 other locations)
Trial IDNCT06489028 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of allo-APZ2-CVU, a treatment involving allogeneic ABCB5-positive dermal mesenchymal stromal cells, for patients with therapy-resistant chronic venous ulcers (CVUs). The study is designed as a randomized, placebo-controlled, double-blind, multicenter, international phase III trial. Participants will receive either the treatment or a placebo, with follow-up assessments for wound healing, pain, and quality of life over an 18-week period. The trial will document wound healing through standardized photography and measure wound size at multiple visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic venous leg ulcers that have not healed despite previous treatments.

Not a fit: Patients with ulcers present for more than 15 years or those with certain comorbidities may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients suffering from chronic venous ulcers that have not responded to standard therapies.

How similar studies have performed: Other studies using similar cell-based therapies have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients at least 18 years old;
2. 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;
3. Wound size at V1 and V2 between 1 and 25 cm˄2 as measured by standardized photography;
4. 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;
5. Body mass index between 15 and 50 kg/m²;
6. Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures;
7. Women of childbearing potential must have a negative urine pregnancy test at Visit 1;
8. 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:

1. Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
2. Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) \>9.0% (75 mmol/mol) (measured by blood test);
3. Peripheral Artery Disease including claudication with need of treatment or intervention;
4. Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis;
5. Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1;
6. 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;
7. Acute wound infection of ulcer requiring treatment as judged clinically;
8. 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;
9. 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;
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. Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo;
13. Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1;
14. Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase;
15. Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion);
16. Employees of the sponsor, or employees or relatives of the investigator(s).

Where this trial is running

Hialeah, Florida and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous Leg UlcerChronic Venous UlcerABCB5AllogeneicDermal mesenchymal stromal cellsvaricose ulcerskin ulceradvanced therapy medicinal product
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.