cenplacel (PDA-002) / Celularity - LARVOL DELTA

Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomised, Double-Blind, Placebo-Controlled Trial. (PubMed, Int Wound J) - "PDA-002 shows promise as a breakthrough treatment for diabetic foot ulcers and peripheral artery disease, demonstrating efficacy with two intramuscular doses and no re-treatment. Trial Registration: ClinicalTrials.gov identifier: NCT # 02264288."

Clinical • Journal • P2 data • Cardiovascular • Peripheral Arterial 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

Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease (clinicaltrials.gov) - P2; N=159; Terminated; Sponsor: Celularity Incorporated; Trial completion date: Nov 2018 ➔ Feb 2018; Active, not recruiting ➔ Terminated; Trial primary completion date: Nov 2018 ➔ Feb 2018; Business decision with all subjects completing at least 1 year follow-up

Clinical • Trial completion date • Trial primary completion date • Trial termination