pp-170 Suspension for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Chronic venous ulcers (CVU) — non-healing lower extremity ulcers in adults
Clinical stage: Phase 3 — CVU-01 trial ongoing
Modality: Cell therapy (allogeneic ABCB5+ skin-derived mesenchymal stromal cells; off-the-shelf)
Mechanism / Target: ABCB5+ MSCs promote tissue repair via anti-inflammatory cytokines, angiogenesis stimulation, and fibroblast activation; reduce chronic wound inflammation and accelerate re-epithelialization
Route / form: Intravenous infusion
Differentiation: Allogeneic ready-to-use product; Phase 2 ABCB5+ MSC trials showed healing in hard-to-treat venous ulcers; addresses large unmet need in elderly patients with recalcitrant CVU
Manufacturer #39193
Clinical-stage cell therapy company specialising in ABCB5-positive mesenchymal stromal cells. Develops allogeneic off-the-shelf MSC therapies for rare, chronic wounds and skin diseases. Wholly owned EU-GMP-compliant manufacturing and Phase 3 pipeline in rare dermatological conditions.
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