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

NCT06489028 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: allo-APZ2-CVU-III2024-512720-11-00U1111-1305-5114
• Study Type: interventional
• Target: 250
• Locations: 12 countries
• Sites: 15

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.

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 III

Outcome Measures

Primary Outcomes (1)

• Complete wound closure

  Complete wound closure already persisting for at least two weeks

  18 weeks

Secondary Outcomes (1)

• Complete wound closures at each post-baseline follow-up visit

  at each post-baseline follow-up visit (starting the day after intervention until month 16)

Study Arms (2)

Verum

EXPERIMENTAL

Drug: allo-APZ2-CVU

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

allo-APZ2-CVU DRUG

Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)

Verum

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Employees of the sponsor, or employees or relatives of the investigator(s).

Sponsors & Collaborators

• RHEACELL GmbH & Co. KG: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (15)

RHEACELL Clinical Trial Site

Hialeah, Florida, 33012, United States

Location

RHEACELL Clinical Trial Site

Miami, Florida, 33136, United States

Location

RHEACELL Clinical Trial Site

Boston, Massachusetts, 02114, United States

Location

RHEACELL Clinical Trial Site

Minneapolis, Minnesota, 55455, United States

Location

RHEACELL Clinical Trial Site

Multiple Locations, Austria

Location

RHEACELL Clinical Trial Site

Multiple Locations, Czechia

Location

RHEACELL Clinical Trial Site

Multiple Locations, France

Location

RHEACELL Clinical Trial Site

Several Locations, Germany

Location

RHEACELL Clinical Trial Site

Multiple Locations, Hungary

Location

RHEACELL Clinical Trial Site

Multiple Locations, Italy

Location

RHEACELL Clinical Trial Site

Multiple Locations, Netherlands

Location

RHEACELL Clinical Trial Site

Multiple Locations, Poland

Location

RHEACELL Clinical Trial Site

Multiple Locations, Slovakia

Location

RHEACELL Clinical Trial Site

Multiple Locations, Sweden

Location

RHEACELL Clinical Trial Site

Multiple Locations, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer; Skin Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anna Moessmer

  RHEACELL GmbH & Co. KG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 5, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

FR (1); SL (1); GB (1); DE (1); IT (1); HU (1); PL (1); CZ (1); AU (1); US (4); SE (1); NL (1)