Drug Profile

Amniotic cell therapy - NuCel

Alternative Names: Human amniotic allograft; NuCel; ReNu™

Latest Information Update: 25 Dec 2025

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At a glance

Originator NuCel
Class Cell therapies
Mechanism of Action Cell replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Marketed Bone disorders
Phase II Intervertebral disc degeneration

Most Recent Events

16 Dec 2025 Organogenesis announces intention to submit rolling BLA to US FDA for Osteoarthritis before the end of December 2025
15 Dec 2025 Organogenesis announces completion of a planned Type-B meeting with the US FDA in Osteoarthritis
11 Jan 2025 Amniotic cell therapy - NuCel receives Regenerative Medicine Advanced Therapy (RMAT) status for Osteoarthritis in USA

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