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MESOBLAST LTD (MESO)

Mesoblast Limited is a biopharmaceutical firm dedicated to the development and commercialization of allogeneic cell-based therapies. Its global presence extends across the United States, Australia, Singapore, the United Kingdom, and Switzerland. The company addresses a broad spectrum of medical conditions, including cardiovascular, spinal orthopedic disorders, oncology, hematology, and immune-mediated and inflammatory diseases. At the core of its innovation is a proprietary regenerative medicine platform utilizing specialized mesenchymal lineage cells. Currently, several of Mesoblast's leading product candidates are undergoing Phase III clinical trials: remestemcel-L, designed for severe, steroid-refractory acute graft versus host disease and acute respiratory distress syndrome associated with COVID-19; Rexlemestrocel-L, aimed at advanced chronic heart failure; and MPC-06-ID, intended for chronic low back pain stemming from degenerative disc disease. Additionally, MPC-300-IV is being developed for biologic-refractory rheumatoid arthritis and diabetic nephropathy. The company has cultivated strategic partnerships to advance its pipeline and market reach. These collaborations include Tasly Pharmaceutical Group for the distribution of MPC-150-IM (heart failure) and MPC-25-IC (heart attacks) in China; JCR Pharmaceuticals Co. Ltd. for therapies addressing wound healing in patients with epidermolysis bullosa; and Grünenthal for the development and commercialization of cell therapy solutions for chronic low back pain. Mesoblast Limited was established in 2004 and maintains its headquarters in Melbourne, Australia.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

Mesoblast Limited logo

Mesoblast Limited

NASDAQ:MESOHealthcare
-3.25%$15.16
AH$15.30+0.92%vs close
Mkt Cap$1.97B
Float83.38M
O/S129.85M
Vol
$ Vol
RVOL
Inst Own3.0%
SI3.9%
Earnings
Dilution
Mesoblast Limited logoNASDAQ:MESO$15.16-3.25%
Upcoming Catalysts
Phase Distribution
39 lead-sponsored trials·1 active·30 completed
Phase 11
Phase 1/28
Phase 213
Phase 312
Not applicable5
(3 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)

    Prochymal®, Placebo

    Graft Versus Host Disease

    Enrollment
    260
    Start
    Aug 2006
    Primary Completion
    Dec 2008
    Completion
    May 2009
    NCT00366145
  • Phase 3
    Completed

    Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

    Prochymal®, Placebo

    Crohn's Disease

    Enrollment
    330
    Start
    Sep 2007
    Primary Completion
    Sep 2014
    Completion
    Sep 2014
    NCT00482092
  • Phase 3
    Completed

    Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

    Placebo, PROCHYMAL adult human mesenchymal stem cells

    Crohn's Disease

    Enrollment
    98
    Start
    Sep 2007
    Primary Completion
    Jul 2009
    Completion
    Apr 2011
    NCT00543374
  • Phase 3
    Completed

    Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)

    Prochymal®

    Graft Versus Host Disease

    Enrollment
    192
    Start
    Jan 2008
    Primary Completion
    Jul 2009
    Completion
    May 2010
    NCT00562497
  • Phase 3
    Completed

    Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

    Prochymal®

    Crohn's Disease

    Enrollment
    73
    Start
    Nov 2010
    Primary Completion
    Sep 2014
    Completion
    Sep 2014
    NCT01233960
  • Phase 3
    Completed

    P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies

    Infusion of one MPC expanded cord unit and one unexpanded cord unit, Infusion of two unexpanded cord blood units.

    Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia +2

    Enrollment
    49
    Start
    Aug 2013
    Primary Completion
    Sep 2016
    Completion
    May 2017
    NCT01854567
  • Phase 3
    Completed

    Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure

    Rexlemestrocel-L

    Chronic Heart Failure

    Enrollment
    565
    Start
    Mar 2014
    Primary Completion
    Jan 2020
    Completion
    Jan 2020
    NCT02032004
  • Phase 3
    Completed

    A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)

    remestemcel-L

    Grade B aGVHD, Grade C aGVHD +1

    Enrollment
    55
    Start
    Jun 2015
    Primary Completion
    Apr 2018
    Completion
    Apr 2018
    NCT02336230
  • Phase 3
    Completed

    Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain

    Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture

    Degenerative Disc Disease

    Enrollment
    404
    Start
    Mar 2015
    Primary Completion
    May 2020
    Completion
    Jun 2021
    NCT02412735
  • Phase 3
    Completed

    Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD

    Remestemcel-L

    Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease +1

    Enrollment
    32
    Start
    Oct 2015
    Primary Completion
    Jun 2018
    Completion
    Jun 2018
    NCT02652130
  • Phase 3
    Active, not recruiting

    Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain

    Rexlemestrocel-L + HA mixture, Saline

    Degenerative Disc Disease

    Enrollment
    300
    Start
    Jul 2024
    Primary Completion
    Jul 2027est.
    Completion
    Jul 2028est.
    NCT06325566
  • Phase 3
    Not yet recruiting

    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease

    Remestemcel-L-rknd

    GVHD - Graft-Versus-Host Disease

    Enrollment
    180
    Start
    Aug 2026est.
    Primary Completion
    Feb 2028est.
    Completion
    Jul 2028est.
    NCT07568535
  • Phase 2
    Withdrawn

    OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies

    autologous expanded mesenchymal stem cells OTI-010, busulfan

    Graft Versus Host Disease, Leukemia +1

    Enrollment
    0
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT00081055
  • Phase 2
    Completed

    Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)

    Prochymal® - 2 Million cells/kg, Prochymal®- 8 Million cells/kg

    Graft Vs Host Disease

    Enrollment
    32
    Start
    Apr 2005
    Primary Completion
    Jul 2006
    Completion
    Jul 2008
    NCT00136903
  • Phase 2
    Completed

    Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants

    Prochymal

    Graft Versus Host Disease

    Enrollment
    11
    Start
    Nov 2005
    Primary Completion
    Apr 2006
    Completion
    Feb 2007
    NCT00284986
  • Phase 2
    Completed

    Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease

    Prochymal™ adult human mesenchymal stem cells, adult human mesenchymal stem cells

    Crohn's Disease

    Enrollment
    10
    Start
    Mar 2006
    Primary Completion
    Jul 2006
    Completion
    Jul 2006
    NCT00294112
  • Phase 2
    Completed

    PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

    Prochymal™, Placebo

    Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema +1

    Enrollment
    62
    Start
    Mar 2008
    Primary Completion
    Mar 2009
    Completion
    Aug 2010
    NCT00683722
  • Phase 2
    Completed

    PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)

    PROCHYMAL®, Placebo

    Type 1 Diabetes Mellitus, Type 1 Diabetes +2

    Enrollment
    63
    Start
    Jun 2008
    Primary Completion
    Dec 2010
    Completion
    Dec 2011
    NCT00690066
  • Phase 2
    Completed

    A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure

    Mesenchymal Precursor Cells (MPCs), Mesenchymal Precursor Cells (MPCs)

    Heart Failure

    Enrollment
    60
    Start
    Aug 2008
    Primary Completion
    Jun 2011
    Completion
    Jul 2013
    NCT00721045
  • Phase 2
    Completed

    Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

    Prochymal®, Placebo

    Myocardial Infarction

    Enrollment
    220
    Start
    Mar 2009
    Primary Completion
    May 2011
    Completion
    Mar 2016
    NCT00877903
  • Phase 2
    Completed

    Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion

    Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse

    Degenerative Disc Disease, Degenerative Spondylolisthesis +1

    Enrollment
    24
    Start
    Sep 2009
    Primary Completion
    Jul 2012
    Completion
    Jul 2014
    NCT00996073
  • Phase 2
    Completed

    Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy

    NeoFuse

    Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis +1

    Enrollment
    24
    Start
    Jun 2010
    Primary Completion
    Jul 2013
    Completion
    Jul 2014
    NCT01097486
  • Phase 2
    Completed

    Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain

    Single Dose MPCs Injection, Single Dose MPCs Injection

    Degenerative Disc Disease

    Enrollment
    100
    Start
    Aug 2011
    Primary Completion
    Jul 2013
    Completion
    Jul 2015
    NCT01290367
  • Phase 2
    Completed

    Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction

    Mesenchymal Precursor Cells (MPC) 12.5 M, Mesenchymal Precursor Cells (MPC) 25 M

    Acute Myocardial Infarction

    Enrollment
    106
    Start
    Mar 2013
    Primary Completion
    Apr 2021
    Completion
    Apr 2021
    NCT01781390
  • Phase 2
    Completed

    A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor

    Allogeneic Mesenchymal Precursor Cells, Normal Saline

    Rheumatoid Arthritis

    Enrollment
    48
    Start
    Jul 2013
    Primary Completion
    May 2016
    Completion
    Mar 2017
    NCT01851070

1-25 of 39

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