cenplacel-L (PDA-001) / Celularity - LARVOL DELTA

Celularity’s Placental-Derived Allogeneic Cell Therapy Provides Clinically Meaningful Benefit and Durable Biological Effect in Patients with Moderate to Severe Crohn’s Disease in Phase 1, Phase 1b/2a and Phase 1b Studies (GlobeNewswire) - "Celularity Inc...announced today that its re-analysis of long term follow-up data from three legacy Phase 1, Phase 1b/2a and Phase 1b studies of its legacy placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy in moderate-to-severe Crohn’s disease patients showed clinically meaningful and durable benefit for up to two years in the limited number of patients studied and warrants further investigation. These studies also identified the optimal MLASC treatment schedule to be a single treatment course of two infusions seven days apart, with no further maintenance treatment required during the clinical study and follow-up period."

Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease

Phase 2a Randomized Controlled Study Investigating the Safety and Efficacy of PDA-002 in Diabetic Peripheral Neuropathy. (PubMed, J Peripher Nerv Syst) - "Mesenchymal stem cells represent a novel mechanism for treating diabetic neuropathy and are well tolerated. Preliminary results highlight the need of further investigation of PDA-001 as a disease modifying agent for treatment of DPN."

Clinical • Journal • P2a data • Diabetes • Diabetic Neuropathy • Immune Modulation • Inflammation • Metabolic Disorders • Pain

Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: New York Medical College; N=20 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CNS Disorders

Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: New York Medical College; Trial completion date: Aug 2021 ➔ Jan 2022; Trial primary completion date: Aug 2020 ➔ Jan 2021

Trial completion date • Trial primary completion date • Biosimilar • Cardiovascular • Reperfusion Injury

A phase 1b, randomised, placebo-controlled, multiple-dose study of human placenta-derived cells (PDA-001) for the treatment of adults with multiple sclerosis (ECTRIMS 2012) - Presentation time: Thursday, October 11, 2012, 15:30 - 17:00; P1b, N=16; Most pts had either stable or decreasing EDSS except one pt who showed increase in T2 and Gd lesions during an MS flare; PDA-001 infusions appeared safe & well tolerated in pts with RRMS and SPMS; A P2 study in this patient population is planned

Anticipated P2 data • P1 data • Multiple Sclerosis

HPDSC+HIE: Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: New York Medical College; Initiation date: Jan 2017 ➔ Aug 2017

Trial initiation date • Biosimilar • Reperfusion Injury