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Mesoblast

Mesoblast logo
🇺🇸United States
Ownership
Subsidiary
Established
2001-01-01
Employees
73
Market Cap
$733.9M
Website
http://www.angioblast.com
Introduction

Mesoblast Ltd. is a biopharmaceutical company, which engages in the research, development, and market of mesenchymal lineage adult stem cell technology platform. Its medicines target cardiovascular diseases, spine orthopedic disorders, oncology and hematology, immune-mediated, and inflammatory diseases. The company was founded by Silviu Itescu on June 8, 2004 and is headquartered in Melbourne, Australia.

Clinical Trials

38

Active:15
Completed:18

Trial Phases

4 Phases

Phase 1:15
Phase 2:8
Phase 3:8
+1 more phases

Drug Approvals

1

FDA:1

Drug Approvals

RYONCIL

Approval Date
Mar 3, 2025
FDA

Clinical Trials

Distribution across different clinical trial phases (32 trials with phase data)• Click on a phase to view related trials

Phase 1
15 (46.9%)
Phase 2
8 (25.0%)
Phase 3
8 (25.0%)
Not Applicable
1 (3.1%)

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
Conditions
Grade B Acute Graft Versus Host Disease
Grade C Acute Graft Versus Host Disease
Grade D Acute Graft Versus Host Disease
First Posted Date
2016-01-11
Last Posted Date
2022-03-16
Lead Sponsor
Mesoblast, Inc.
Target Recruit Count
32
Registration Number
NCT02652130
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

CHOC Children's Hospital of Orange County, Orange, California, United States

🇺🇸

UCSF Benioff Children's Hospital, San Francisco, California, United States

and more 17 locations

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
Conditions
Grade D aGVHD
Grade B aGVHD
Grade C aGVHD
Interventions
First Posted Date
2015-01-12
Last Posted Date
2022-03-17
Lead Sponsor
Mesoblast, Inc.
Target Recruit Count
55
Registration Number
NCT02336230
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

Children's Hospital of Orange County, Orange, California, United States

🇺🇸

University of California at San Francisco, San Francisco, California, United States

and more 17 locations

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

Phase 3
Completed
Conditions
Chronic Heart Failure
First Posted Date
2014-01-09
Last Posted Date
2022-01-10
Lead Sponsor
Mesoblast, Inc.
Target Recruit Count
566
Registration Number
NCT02032004
Locations
🇺🇸

Mesoblast Investigational Site 10757 - Cardiology, P.C., Birmingham, Alabama, United States

🇺🇸

Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States

🇺🇸

Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center, Gilbert, Arizona, United States

and more 56 locations

Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction

Phase 2
Completed
Conditions
Acute Myocardial Infarction
First Posted Date
2013-02-01
Last Posted Date
2022-06-23
Lead Sponsor
Mesoblast, Inc.
Target Recruit Count
106
Registration Number
NCT01781390

Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Conditions
Crohn's Disease
First Posted Date
2012-01-16
Last Posted Date
2020-03-10
Lead Sponsor
Mesoblast, Inc.
Registration Number
NCT01510431
Locations
🇺🇸

Unviersity of California, San Francisco, San Francisco, California, United States

🇺🇸

Stormont-Vail, Topeka, Kansas, United States

🇺🇸

Mount Sinai Hospital, New York, New York, United States

and more 1 locations
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News

NextCell Pharma Strengthens Commercial Strategy with Appointment of MSC Therapy Expert Dr. Eric Strati

NextCell Pharma has appointed Dr. Eric Strati, former executive at Takeda, Mesoblast, and Novartis, to its Board of Advisors to advance commercial strategy for ProTrans, its type 1 diabetes cell therapy.

Mesoblast's Ryoncil Receives US FDA Orphan Drug Approval, Driving 15% Share Price Surge

Mesoblast received US FDA orphan drug approval for Ryoncil, granting seven years of market exclusivity and driving a 15% share price increase over one week.

Myocardial Infarction Therapeutics Pipeline Shows Promise with Over 45 Companies Involved

The myocardial infarction therapeutics pipeline is robust, featuring over 45 companies developing more than 50 potential drugs.

FDA Roundup: Approvals, Breakthrough Designations, and Clinical Holds in Neurology and Rare Diseases

• The FDA granted breakthrough therapy designation to STK-001 for Dravet syndrome, highlighting its potential to improve upon current treatments by restoring NaV1.1 protein levels. • Tolebrutinib received breakthrough therapy designation for non-relapsing secondary progressive multiple sclerosis based on phase 3 trial results showing delayed disability progression. • The FDA placed a clinical hold on PepGen’s PGN-EDO51 phase 2 study for Duchenne muscular dystrophy, pending further clarification from the agency.

Mesoblast Receives FDA Approval for First MSC Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease

• Mesoblast's mesenchymal stromal cell (MSC) therapy has gained FDA approval for steroid-refractory acute graft-versus-host disease (SR-aGVHD). • This approval marks a significant advancement in regenerative medicine, highlighting the potential of MSC therapies. • Pluri Inc. congratulates Mesoblast, emphasizing the importance of this milestone for the entire field of cellular medicine. • The FDA's decision underscores the opportunity to accelerate the development of MSC-based therapies globally, according to Pluri.

FDA Approves Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-versus-Host Disease

The FDA has approved Ryoncil (remestemcel-L-rknd) as the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients.

Mesoblast's Ryoncil Receives FDA Approval for Pediatric Blood Disorder Treatment

Mesoblast's Ryoncil has been approved by the FDA for treating children with a severe blood disorder, marking a significant milestone for the company.

ASX Biotechs Gear Up for Critical Phase III Trial Results in 2025

Several ASX-listed biotech companies are anticipating crucial Phase III clinical trial results in 2025, which could significantly impact their market value and future prospects.

Revascor Shows Promise in DREAM-HF Trial for Ischemic Heart Failure

Mesoblast's Revascor demonstrated improved survival and reduced major morbidity in high-risk ischemic heart failure patients with inflammation.

FDA Approves Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric SR-aGVHD

The FDA has approved Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States.

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