mesenchymal precursor cells (MPC) / Mesoblast - LARVOL DELTA

Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells With and Without Hyaluronic Acid for Treatment of Chronic Low Back Pain: A Prospective, Randomized, Double Blind, Concurrent-Controlled 36-Month Study. (PubMed, Spine J) - "While the primary and secondary efficacy endpoints were not met in all subjects, MPC+HA treatment showed a significant reduction in pain compared to control that was enhanced in subjects with CLBP duration less than 68 months. Intra-discal injection of MPC+HA is a minimally invasive non-opioid therapy that appears to be safe and demonstrates reduction in pain through 24 months compared to control with enhanced results in subjects with mDDD that have had CLBP less than 68 months."

Clinical • Journal • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. (PubMed, Eur J Heart Fail) - "Ischaemic aetiology and inflammation were identified as major risk factors for MACE in control DREAM-HF patients. A single intramyocardial MPC administration produced the most significant, sustained reduction in 2-point and 3-point MACE in patients with ischaemic HFrEF and inflammation."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation • Myocardial Infarction • CRP

Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy in Patients With Heart Failure. (PubMed, J Am Coll Cardiol) - "The primary and secondary endpoints of the trial were negative. Positive signals in prespecified, and post hoc exploratory analyses suggest MPCs may improve outcomes, especially in patients with inflammation."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Inflammation • Myocardial Infarction • CRP

[VIRTUAL] Randomized Trial of Targeted Transendocardial Delivery of Mesenchymal Precursor Cells in High-Risk Chronic Heart Failure Patients With Reduced Ejection Fraction (AHA 2021) - P3 | "The durable risk reduction with MPCs in irreversible morbidity and CV death in HFrEF patients with systemic inflammation likely reflects the unique mechanisms of this therapy and its potential benefit when used at earlier disease stages. Future trials may target NYHA class II high-risk chronic HFrEF patients with biomarker evidence of inflammation. ClinicalTrials.gov NCT02032004"

Clinical • Late-breaking abstract • Atherosclerosis • Cardiovascular • Congestive Heart Failure • Dyslipidemia • Heart Failure • Immune Modulation • Immunology • Inflammation • Myocardial Infarction • CRP

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (clinicaltrials.gov) - P3; N=566; Completed; Sponsor: Mesoblast, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain (clinicaltrials.gov) - P2; N=100; Completed; Sponsor: Mesoblast, Ltd.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Demo Pain • Pain

AMICI: Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction (clinicaltrials.gov) - P2; N=105; Active, not recruiting; Sponsor: Mesoblast, Ltd.; Recruiting ➔ Active, not recruiting; N=225 ➔ 105

Enrollment change • Enrollment closed • Acute Coronary Syndrome • Biosimilar • Cardiovascular • Immunology

A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNF Alpha Inhibitor (clinicaltrials.gov) - P2; N=48; Active, not recruiting; Sponsor: Mesoblast, Ltd.; Trial primary completion date: Apr 2017 ➔ May 2016

Trial primary completion date • Biosimilar • Immunology • Rheumatoid Arthritis

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (clinicaltrials.gov) - P3; N=566; Active, not recruiting; Sponsor: Mesoblast, Inc.; Trial completion date: Dec 2019 ➔ May 2020; Trial primary completion date: Dec 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis (clinicaltrialsregister.eu) - P2; N=90; Ongoing; Sponsor: Mesoblast, Inc

Clinical • New P2 trial

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (clinicaltrials.gov) - P3; N=566; Active, not recruiting; Sponsor: Mesoblast, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed