ACTIVE_NOT_RECRUITING

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

Conditions

Venous Leg Ulcer Chronic Venous Ulcer ABCB5 Allogeneic Dermal mesenchymal stromal cells varicose ulcer skin ulcer advanced therapy medicinal product somatic cell therapy phase III

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-12-26

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06489028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Principal Investigator

Anna Moessmer

STUDY_DIRECTOR

RHEACELL GmbH & Co. KG

Study Locations (Sites)

RHEACELL Clinical Trial Site

Hialeah, Florida, 33012

United States

RHEACELL Clinical Trial Site

Miami, Florida, 33136

United States

RHEACELL Clinical Trial Site

Boston, Massachusetts, 02114

United States

RHEACELL Clinical Trial Site

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: RHEACELL GmbH & Co. KG

Anna Moessmer, STUDY_DIRECTOR, RHEACELL GmbH & Co. KG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-26

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-12-26

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Chronic Venous Ulcer
ABCB5
Allogeneic
Dermal mesenchymal stromal cells
varicose ulcer
skin ulcer
advanced therapy medicinal product
somatic cell therapy
phase III

Additional Relevant MeSH Terms

Venous Leg Ulcer