Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
Scientific Community
Become a Member | Sign in
Home>News>This Article

Mesoblast Receives FDA Clearance for Phase 2 Trial of MPCs in Active RA Patients

Published: Thursday, May 16, 2013
Last Updated: Thursday, May 16, 2013
Bookmark and Share
In addition, a second Phase 2 trial of MPCs as a first-line biologic treatment for active RA is planned to commence in Europe in 1H 2013.

Mesoblast Limited has announced that it has received clearance from the United States Food and Drug Administration (FDA) to commence a Phase 2 clinical trial evaluating a single intravenous infusion of allogeneic, or “off-the-shelf”, Mesenchymal Precursor Cells (MPCs) for the treatment of active rheumatoid arthritis.

The randomized, double-blind placebo-controlled trial is expected to commence during the second quarter 2013, and will recruit across multiple sites in the United States and Australia.

The trial will compare the effects of a single intravenous infusion of allogeneic MPCs dosed at 1 or 2 million cells/kg compared with placebo in 48 patients who have had an incomplete or inadequate response to a biologic inhibitor of the TNF-alpha pathway for active rheumatoid arthritis.

Safety and effectiveness of the MPC therapy will be assessed at multiple time points with the primary endpoints defined as 3 months.

RA is an autoimmune disease caused by aberrant activation of multiple immune pathways involving both monocytes and T cells, ultimately resulting in joint destruction.

Existing biologic treatments target only single immune pathways, resulting in incomplete responses, need for chronic administration, and potentially unacceptable infectious adverse events.

In contrast, Mesoblast's MPCs have been shown in preclinical studies to have a broad immunomodulatory mechanism of action (MOA), simultaneously inhibiting T cells and monocytes involved in inflammation and autoimmunity.

The broader effects of Mesoblast's MPCs on multiple immune pathways suggest that they may be particularly useful agents for reducing the inflammation and permanent joint damage associated with progression of RA.

In a randomized, placebo-controlled study in 30 sheep with collagen-induced arthritis, a model that manifests joint damage characteristic of human RA, treatment with Mesoblast’s MPCs resulted in reduced TNF-alpha, IL-6, and IL-17 in the diseased joint.

In comparison with saline treated controls, synovial tissue from arthritic sheep 30 days after receiving a single intravenous injection of 2 million MPCs/kg showed 88% reduction in IL-6 levels (p=0.029), 83% reduction in TNF-alpha levels (p=0.049), 53% reduction in IL-17 levels (p=0.005), and 43% reduction in infiltrating monocytes/macrophages (p=0.018). MPC-treated animals had a 31% reduction in histopathology severity scores compared with controls (p <0.025).

These findings show that MPCs can concomitantly inhibit both Th17 T cells and pro-inflammatory monocytes, and improve synovial tissue pathology.

This provides a rationale for their potential use as both a first-line biologic treatment in those not responding to conventional anti-rheumatic agents and in patients with incomplete responses to biologic inhibitors of the TNF-alpha pathway alone.

Mesoblast Chief Executive Professor Silviu Itescu said: “We believe that the broad immunomodulatory effects of our MPCs could provide a tangible benefit to patients with debilitating autoimmune diseases, including RA. This is the first in a series of programs designed to establish the credentials of our intravenous product formulation for a broad-based spectrum of inflammatory and immunologic conditions.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Pharmaceutical Executive Joins Mesoblast as Chief Financial Officer
Appointment of Mr Paul Hodgkinson as Company’s Chief Financial Officer.
Tuesday, August 26, 2014
FDA Agreement on Mesoblast’s Use of Singapore Manufacturing Facility for MPCs Clinical Trial Production
New facility will support product delineation strategies, increase geographical reach, and reduce risk of single site reliance.
Tuesday, May 21, 2013
Mesoblast Completes A$170m Private Placement
Company now has cash reserves of approximately A$332 million.
Tuesday, March 19, 2013
Mesoblast Reports Half-Year 2013 Financial Results
Provides strategic update on key areas of product development.
Tuesday, February 12, 2013
Key Mesenchymal Precursor Cell Patents Granted in United States and China
New granted claims confer exclusive, long-term commercial rights in the world's largest established and emerging healthcare markets.
Friday, February 08, 2013
New Teva Representative Joins Mesoblast Board Of Directors
Appointment of Dr Ben-Zion Weiner as a non-executive Director of Mesoblast.
Monday, October 22, 2012
Mesoblast Provides Corporate Strategy for Product Development to Treat Neurologic Conditions
Exclusive commercial rights to develop neuroregenerative dental pulp stem cells.
Tuesday, June 12, 2012
Mesoblast Receives FDA Clearance for Phase 2 Clinical Trial of Proprietary Stem Cell Therapy in Type 2 Diabetes
Trial will be randomized, placebo-controlled to evaluate safety and effectiveness over 3 months of a single intravenous injection of one of three progressively increasing MPC doses in 60 Type 2 diabetes patients with elevated blood glucose levels.
Tuesday, May 08, 2012
Intervertebral Disc Repair Phase 2 Trial Update
Rapid patient accrual, enrolment reaches half way mark positive preclinical study results published in premier neurosurgical journal.
Wednesday, April 18, 2012
Mesoblast Half-Year Results
Strong financial position underpins company’s ability to deliver in increased value from broadened range of stem cell therapeutics.
Tuesday, February 28, 2012
Mesoblast Presented Positive Phase 2 Results at AHA
Revascor™ anticipated to progress to Phase 3 trial in first half of 2012.
Friday, November 18, 2011
Mesoblast Cleared to Begin First Phase 2 Clinical Trial for Eye Diseases
Mesoblast receives regulatory clearance to begin Phase 2 trial for wet Age-related Macular Degeneration.
Thursday, October 27, 2011
Mesoblast Receives Clearance to Begin First European Trial of Allogeneic or ‘Off-The-Shelf’ Stem Cell Treatment for Heart Attacks
Company receives clearance to begin Phase 2 clinical trial for Revascor™ in conjunction with angioplasty and stent procedures.
Tuesday, September 06, 2011
Single Dose of Proprietary Adult Stem Cells Regenerates Damaged Pancreas
Stem cell treatment induced two-fold increase in total numbers of pancreatic islets, and increase in insulin-producing beta cells.
Monday, December 21, 2009
Mesoblast's Stem Cells Protect Knee Cartilage in Osteoarthritis
Mesoblast's allogeneic, or donor unrelated, adult stem cells protected knee joint cartilage against destruction in osteoarthritis preclinical trials.
Wednesday, August 29, 2007
Scientific News
Snapshot Turns T Cell Immunology on its Head
New research may have implications for 1 diabetes sufferers.
Developing a Gel that Mimics Human Breast for Cancer Research
Scientists at the Universities of Manchester and Nottingham have been funded to develop a gel that will match many of the biological structures of human breast tissue, to advance cancer research and reduce animal testing.
Lung Repair and Regeneration Gene Discovered
New role for hedgehog gene offers better understanding of lung disease.
Restoring Vision with Stem Cells
Age-related macular degeneration (AMRD) could be treated by transplanting photoreceptors produced by the directed differentiation of stem cells, thanks to findings published today by Professor Gilbert Bernier of the University of Montreal and its affiliated Maisonneuve-Rosemont Hospital.
The Age of Humans Controlling Microbes
Engineered bacteria could soon be used to detect environmental toxins, treat diseases, and sustainably produce chemicals and fuels.
Gene Expression: A Snapshot of Stem Cell Development
New genes found that regulate development of stem cells.
Tissue-Engineered Colon from Human Cells
A study by scientists at Children’s Hospital Los Angeles has shown that tissue-engineered colon derived from human cells is able to develop the many specialized nerves required for function, mimicking the neuronal population found in native colon.
Tension Helps Heart Cells Develop Normally in the Lab
Stanford engineers have uncovered the important role tension plays in growing heart cells out of the body.
Urine Excretion From Stem Cell-Derived Kidneys
Researchers report a strategy for enabling urine excretion from kidneys grown from stem cells.
Stem Cell Research Hints at Evolution of Human Brain
Researchers at UC San Francisco have succeeded in mapping the genetic signature of a unique group of stem cells in the human brain that seem to generate most of the neurons in our massive cerebral cortex.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos