Active — Not RecruitingPhase 3

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)

United States, Austria250 participantsStarted 2024-12-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕. 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;

What they're measuring

Complete wound closure

Timeframe: 18 weeks

Trial details

NCT IDNCT06489028

SponsorRHEACELL GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Venous Leg Ulcer trials