Positive Trial Results of Mesoblast Cell Therapy in Post-Traumatic Osteoarthritis Published In Arthritis Research & Therapy
August 16 2017 - 6:00AM
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that the
Phase 2a trial of its Mesenchymal Precursor Cells (MPCs) for
prevention of radiographic and clinical features of knee
osteoarthritis after traumatic injury has been published in the
peer-reviewed journal Arthritis Research & Therapy. The results
showed that a single intra-articular injection of Mesoblast’s
product candidate MPC-75-IA reduced cartilage loss and bone
changes by six months, and improved pain and function for over two
years, when compared to controls.
The paper, entitled ‘Safety, tolerability, clinical
and joint structural outcomes of a single intra-articular injection
of allogeneic mesenchymal precursor cells in patients post
anterior cruciate ligament reconstruction: a controlled
double-blind randomized trial’, concluded that MPCs may
modulate the inflammation-related pathological processes that are
associated with post-traumatic knee osteoarthritis.
The trial's senior author, Professor Flavia Cicuttini, Head
Musculoskeletal Unit, Department of Epidemiology and Preventive
Medicine School of Public Health and Preventive Medicine at Monash
University, Australia, said: “As there are no treatments that slow
progression of osteoarthritis, these results are very exciting for
a population who are at high risk of developing this crippling
condition.”
“In this study we found that a single injection of 75 million
mesenchymal precursor cells was well tolerated and appeared to slow
the onset of a number of the early changes at the knee that are
common following knee injury and signify the development of knee
osteoarthritis. Larger studies are warranted to confirm
whether this treatment will slow or even prevent the development of
knee osteoarthritis following early joint injuries,” stated
Professor Cicuttini.
Trial design and key findings were:
- A double-blind placebo-controlled trial randomized (2:1) 17
patients aged 18-40 who had undergone ACL reconstruction 4-6 weeks
earlier to either a single intra-articular injection of
75 million allogeneic MPCs plus hyaluronic acid (MPC+HA, n=11) or
hyaluronic acid (HA, n=6) alone. Pain, function and quality of
life parameters were measured over 24 months using the composite of
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) and the Short
Form Health Survey (SF-36, a 36-item, patient-reported survey of
patient health). Joint space width reflecting cartilage thickness
was measured by X-ray, and structural changes in the joint were
measured by magnetic resonance imaging (MRI)
- Intra-articular MPC administration post–ACL reconstruction was
well tolerated
- Patients who were treated with MPC+HA had significantly greater
improvement in KOOS symptoms and pain at 18 months (both p=0.03)
and 24 months (p=0.04 and 0.02, respectively), compared with HA
controls
- MPC+HA treated patients showed greater improvements in KOOS
pain, symptom, activities of daily living, and SF-36 bodily pain
scores at 6,12 and 24 months (p<0.05), compared with the HA
group
- The MPC+HA group had reduced medial and lateral tibiofemoral
joint space narrowing (p<0.05), less tibial bone expansion (0.5%
vs 4.0%, p=0.02 over 26 weeks), and a trend towards reduced tibial
cartilage volume loss (0.7% vs -4.0%, p=0.10 over 26 weeks) than
the HA controls
- The proposed mechanisms of action relevant to this indication
include anti-inflammatory and immunomodulatory effects on the
injury induced production of inflammatory mediators within joint
tissues that cause the clinical symptoms and eventual joint
destruction
- The study findings warrant further investigation of MPCs as a
potential disease modifying agent for the treatment of early joint
injuries
About Post-Traumatic
OsteoarthritisOsteoarthritis (OA) is a common and
debilitating disease that affects approximately 27 million people
in the United States4. Post-traumatic OA of the knee, hip and
ankle accounts for approximately 5.6 million cases of OA in the
United States4. There are approximately 250,000 cases of ACL tears
annually in the USA, more than 70% of ACL reconstructions occur in
patients under the age of 65 years4,5. Despite corrective ACL
surgery, as many as 80% of knees post-ACL injury will progress to
radiographic and symptomatic OA after 5 to 15 years6. Similar
outcomes are seen with the approximately 1 million meniscal
reconstruction procedures performed annually in the United States7.
While existing treatments for post-traumatic OA predominantly focus
on reducing pain and inflammation, none have been shown to restore
joint structural changes or delay the onset and/or progression of
OA.
ACL reconstruction is considered to be a cost-effective
treatment strategy, however in the United States there is still a
significant annual cost of about $2.8 billion attributable to the
long-term development of OA8. An innovative therapy that
demonstrates disease modifying effects on OA development or
progression would be expected to deliver significant annual
societal cost savings.
1
https://www.cdc.gov/injury/erpo/icrc/2009/1-r49-ce001495-01.html2
Arthritis & Rheumatology; Early Knee Osteoarthritis Is Evident
One Year Following Anterior Cruciate Ligament Reconstruction: A
Magnetic Resonance Imaging Evaluation; Adam G. Gulvenor, et al;
April 20153 American Journal of Sports Medicine; The long-term
consequence of anterior cruciate ligament and meniscus
injuries;35:1756–69, Lohmander LS, Englund PM, Dahl LL, Roos EM.;
20074 Thomas A, Hubbard-Turner T, Wikstrom E (2017)
Epidemiology of Psttraumatic Osteoarthritis. Journal of Athletic
Training 52(6): 491-4965 Abrams G, Frank R, Gupta A (2013) Trends
in Meniscus Repair and Meniscectomy in the United States,
2005-2011. The American Journal of Sports Medicine: 1-76 Simon D,
Mascarenhas R, Saltzman B (2015) The Relationship between Anterior
Cruciate Ligament Injury and Osteoarthritis of the Knee. Advances
in Orthopedics: 1-127 Verdonk R, Verdonk P, Huysse W (2011) Tissue
in Growth After Implantation of a Novel, Biodegradable
Polyurethane Scaffold for Treatment of Partial Meniscal Lesions.
The American Journal of Sports Medicine: 39:774-7828 Mather R,
Koenig L, Kocher M (2013) Societal and Economic Impact of Anterior
Cruciate Ligament Tears. The Journal of Bone and Joint Surgery:
95:1751-9
About MesoblastMesoblast Limited (Nasdaq:MESO)
(ASX:MSB) is a global leader in developing innovative cell-based
medicines. The Company has leveraged its proprietary technology
platform, which is based on specialized cells known as mesenchymal
lineage adult stem cells, to establish a broad portfolio of
late-stage product candidates. Mesoblast’s allogeneic,
‘off-the-shelf’ cell product candidates target advanced stages of
diseases with high, unmet medical needs including cardiovascular
conditions, orthopedic disorders, immunologic and inflammatory
disorders and oncologic/hematologic conditions. For more
information, please visit www.mesoblast.com.
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