COMPANY

Mesoblast

FDA-approved therapeutic company FDA-cleared device company Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Degenerative Disc Disease Crohn's Disease Graft Versus Host Disease Degenerative Spondylolisthesis Spinal Stenosis Myocardial Infarction Graft Vs Host Disease Cervical Degenerative Disc Disease Type 2 Diabetes GVHD - Graft-Versus-Host Disease Chronic Heart Failure Type 1 Diabetes Mellitus Type 1 Diabetes Insulin-Dependent Diabetes Mellitus Juvenile Diabetes Chronic Obstructive Pulmonary Disease Pulmonary Emphysema Chronic Bronchitis Acute Myocardial Infarction Grade B aGVHD Grade C aGVHD Grade D aGVHD Grade B Acute Graft Versus Host Disease Grade C Acute Graft Versus Host Disease Grade D Acute Graft Versus Host Disease Spondylolisthesis Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Hodgkin's Disease Rheumatoid Arthritis Heart Failure Anterior Cruciate Ligament Injury Osteoarthritis Diabetic Nephropathy Prochymal® remestemcel-L NeoFuse Remestemcel-L-rknd

34Trials (company is sponsor)1FDA records (2 yrs)

Timeline

Aug 31, 2026 Trial start III: 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 source ↗
Dec 18, 2024 FDA FDA New drug/biologic (novel): ryoncil (remestemcel-l-rknd) — BLA125706, Dec 18, 2024. Applicant at approval: Mesoblast, Inc. source ↗
Jul 3, 2024 Trial start Phase 3: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain source ↗
Oct 28, 2015 Trial start Phase 3: Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD source ↗
Jun 4, 2015 Trial start Phase 3: 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 A source ↗
Mar 6, 2015 Trial start Phase 3: Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain source ↗
Mar 3, 2014 Trial start Phase 3: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure source ↗
2013-08 Trial start Phase 3: P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies source ↗
2013-07 Trial start Phase 2: 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 source ↗
2013-07 Trial start Phase 1/Phase 2: Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy source ↗
Mar 11, 2013 Trial start Phase 2: Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction source ↗
2012-04 Trial start Phase 1/Phase 2: Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes source ↗
2011-08 Trial start Phase 2: Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain source ↗
Nov 29, 2010 Trial start Phase 3: Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease source ↗
2010-06 Trial start Phase 1/Phase 2: Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion source ↗
2010-06 Trial start Phase 2: Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy source ↗
2009-09 Trial start Phase 2: Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion source ↗
Mar 30, 2009 Trial start Phase 2: Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI) source ↗
2009-03 Trial start Phase 1/Phase 2: Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction source ↗
2008-11 Trial start Phase 1/Phase 2: Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion source ↗
2008-08 Trial start II: 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 F source ↗
Jun 11, 2008 Trial start Phase 2: PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) source ↗
Mar 20, 2008 Trial start Phase 2: PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) source ↗
Jan 31, 2008 Trial start Phase 3: Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD) source ↗
2007-10 Trial start Phase 1/Phase 2: Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF) source ↗

Showing 25 of 32 dated events.

Upcoming milestones

2027-07 (ESTIMATED) · Phase 3 · Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain · NCT06325566
Feb 28, 2028 (ESTIMATED) · III · 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 · NCT07568535

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 34

Record	Title	Phase	Status	Start	Primary completion
NCT06325566	Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain	Phase 3	Active, not recruiting	Jul 3, 2024	2027-07 (estimated)
NCT07568535	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	III	Not yet recruiting	Aug 31, 2026	Feb 28, 2028 (estimated)
NCT02032004	Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure	Phase 3	Completed	Mar 3, 2014	Jan 30, 2020 (actual)
NCT01233960	Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease	Phase 3	Completed	Nov 29, 2010	Sep 15, 2014 (actual)
NCT00543374	Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease	Phase 3	Completed	Sep 17, 2007	2009-07 (actual)
NCT00877903	Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)	Phase 2	Completed	Mar 30, 2009	May 18, 2011 (actual)
NCT00690066	PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)	Phase 2	Completed	Jun 11, 2008	Dec 12, 2010 (actual)
NCT00683722	PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)	Phase 2	Completed	Mar 20, 2008	Mar 9, 2009 (actual)
NCT00482092	Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease	Phase 3	Completed	Sep 17, 2007	Sep 15, 2014 (actual)
NCT00284986	Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants	Phase 2	Completed	Nov 18, 2005	Apr 25, 2006 (actual)
NCT02412735	Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain	Phase 3	Completed	Mar 6, 2015	May 15, 2020 (actual)
NCT01781390	Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction	Phase 2	Completed	Mar 11, 2013	Apr 6, 2021 (actual)
NCT02336230	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)	Phase 3	Completed	Jun 4, 2015	Apr 9, 2018 (actual)
NCT02652130	Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD	Phase 3	Completed	Oct 28, 2015	Jun 15, 2018 (actual)
NCT00366145	Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)	Phase 3	Completed	Aug 17, 2006	Dec 26, 2008 (actual)
NCT00136903	Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)	Phase 2	Completed	Apr 27, 2005	Jul 28, 2006 (actual)
NCT00562497	Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)	Phase 3	Completed	Jan 31, 2008	Jul 14, 2009 (actual)
NCT01106417	Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion	Phase 1/Phase 2	Completed	2010-06	2012-05 (actual)
NCT00549913	Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)	Phase 1/Phase 2	Completed	2007-10	2013-08 (actual)
NCT00996073	Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2	Completed	2009-09	2012-07 (actual)
NCT01854567	P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies	Phase 3	Completed	2013-08	Sep 23, 2016 (actual)
NCT01851070	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	Phase 2	Completed	2013-07	2016-05 (actual)
NCT01290367	Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain	Phase 2	Completed	2011-08	2013-07 (actual)
NCT01576328	Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes	Phase 1/Phase 2	Completed	2012-04	2013-10 (actual)
NCT00810212	Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion	Phase 1/Phase 2	Withdrawn	2008-11	2011-11 (estimated)
NCT00294112	Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease	Phase 2	Completed	Mar 13, 2006	Jul 21, 2006 (actual)
NCT00721045	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	II	Completed	2008-08	2011-06 (actual)
NCT00114452	Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction	Phase 1	Completed	Mar 22, 2005	Oct 4, 2006 (actual)
NCT01510431	Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease	Not listed	No longer available	Not listed	Not listed
NCT00759018	Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD	Not listed	No longer available	Not listed	Not listed
NCT00826046	Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)	Not listed	No longer available	Not listed	Not listed
NCT01097486	Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy	Phase 2	Completed	2010-06	2013-07 (actual)
NCT01088191	Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction	Phase 1/Phase 2	Completed	2009-03	2013-11 (actual)
NCT01843387	Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy	Phase 1/Phase 2	Completed	2013-07	2014-09 (actual)

FDA records (last 2 years)

Dec 18, 2024 FDA New drug/biologic (novel): ryoncil (remestemcel-l-rknd) — BLA125706, Dec 18, 2024. Applicant at approval: Mesoblast, Inc. source ↗