AMESANAR (allogeneic ABCB5-positive mesenchymal stromal cells) / TICEBA - LARVOL DELTA

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: RHEACELL GmbH & Co. KG | Not yet recruiting ➔ Recruiting

Enrollment open • Stroma • Venous Ulcer

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb) (clinicaltrials.gov) - P2 | N=152 | Active, not recruiting | Sponsor: RHEACELL GmbH & Co. KG | Recruiting ➔ Active, not recruiting

Enrollment closed • Stroma • Venous Ulcer

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) (clinicaltrials.gov) - P3 | N=250 | Not yet recruiting | Sponsor: RHEACELL GmbH & Co. KG

New P3 trial • Stroma • Venous Ulcer

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb) (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: RHEACELL GmbH & Co. KG | Phase classification: P2b ➔ P2

Phase classification • Stroma • Venous Ulcer

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb) (clinicaltrials.gov) - P2b | N=200 | Recruiting | Sponsor: RHEACELL GmbH & Co. KG | Trial completion date: Aug 2023 ➔ Jun 2026 | Trial primary completion date: Aug 2023 ➔ Jun 2026

Stroma • Trial completion date • Trial primary completion date • Venous Ulcer

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) (clinicaltrials.gov) - P3 | N=74 | Recruiting | Sponsor: RHEACELL GmbH & Co. KG | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2023 ➔ Oct 2023

Enrollment open • Stroma • Trial initiation date

Improved Wound-Healing of Therapy-Refractory Diabetic Foot Ulcers - an Innovative Therapy Approach Using Allogeneic ABCB5+ Mesenchymal Stromal Cells (WCD 2023) - "Efficient wound-closure at exceptional tolerability and safety was reached for standard-therapy-refractory DFU-patients after ABCB5+MSC application. This was in line with a recent clinical phase-I/IIa trial with 31 therapy-refractory chronic-venous-ulcer patients. A 70% responder-rate with 87% median wound-size reduction and 6 complete closures was reached, allowing for national approval in Germany1."

Stroma • Cardiovascular • Immune Modulation • Infectious Disease • Venous Ulcer • IL1R1

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) (clinicaltrials.gov) - P3 | N=74 | Not yet recruiting | Sponsor: RHEACELL GmbH & Co. KG

New P3 trial • Stroma

Amesanar - stem cells in chronic venous wounds (DDG-TAGUNG 2023) - "Sponsored by RHEACELL"

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over) (clinicaltrials.gov) - P3 | N=74 | Recruiting | Sponsor: RHEACELL GmbH & Co. KG | Not yet recruiting ➔ Recruiting

Enrollment open • Stroma

Skin-Derived ABCB5 Mesenchymal Stem Cells for High-Medical-Need Inflammatory Diseases: From Discovery to Entering Clinical Routine. (PubMed, Int J Mol Sci) - "Therefore, skin-derived ABCB5 MSCs have the potential to provide a breakthrough at the forefront of MSC-based therapies striving to fulfill current unmet medical needs. The most recent milestones in this regard are the approval of a phase III pivotal trial of ABCB5 MSCs for treatment of recessive dystrophic and junctional epidermolysis bullosa by the US Food and Drug Administration, and national market access of ABCB5 MSCs (AMESANAR) for therapy-refractory chronic venous ulcers under the national hospital exemption pathway in Germany."

Journal • Review • Immune Modulation • Immunology • Inflammation • Venous Ulcer

Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa (clinicaltrials.gov) - P1/2 | N=16 | Completed | Sponsor: RHEACELL GmbH & Co. KG | Active, not recruiting ➔ Completed

Trial completion