allo-APZ2-CVU

BIOLOGICAL4 trials

Sponsors

Rheacell GmbH & Co. KG, RHEACELL GmbH & Co. KG

Conditions

Skin Ulcer Venous Stasis ChronicVenous Leg Ulcerchronic venous ulcers (CVU)

Phase 1

Allogeneic ABCB5-positive Stem Cells for Treatment of CVU

CompletedNCT03257098

RHEACELL GmbH & Co. KGSkin Ulcer Venous Stasis Chronic

Start: 2017-11-16End: 2020-06-25Updated: 2020-09-10

Phase 2

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)

CompletedNCT04971161

RHEACELL GmbH & Co. KGSkin Ulcer Venous Stasis Chronic

Start: 2021-08-18End: 2025-11-25Updated: 2025-12-04

Phase 3

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

Active, not recruitingNCT06489028

RHEACELL GmbH & Co. KGVenous Leg Ulcer

Start: 2024-12-26End: 2027-09-30Target: 250Updated: 2025-10-01

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)

Active, not recruitingCTIS2024-512720-11-00

Rheacell GmbH & Co. KGchronic venous ulcers (CVU)

Start: 2025-01-16Target: 207Updated: 2025-10-20