Status:
ACTIVE_NOT_RECRUITING
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
Lead Sponsor:
RHEACELL GmbH & Co. KG
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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).
Key Trial Info
Start Date :
December 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06489028
Start Date
December 26 2024
End Date
September 1 2027
Last Update
October 1 2025
Active Locations (15)
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1
RHEACELL Clinical Trial Site
Hialeah, Florida, United States, 33012
2
RHEACELL Clinical Trial Site
Miami, Florida, United States, 33136
3
RHEACELL Clinical Trial Site
Boston, Massachusetts, United States, 02114
4
RHEACELL Clinical Trial Site
Minneapolis, Minnesota, United States, 55455