This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Mesoblast's NeoFuse Stem Cell Product Shows Positive Results In Phase 2 Lumbar Spinal Fusion Trial

Key points:

  • Phase 2 trial results using Mesoblast's allogeneic, or "off-the-shelf", Mesenchymal Precursor Cells (MPCs) demonstrated rates of fusion success that were comparable to the gold standard bone autograft
  • MPCs were well tolerated with no cell-related serious adverse events and no evidence of any ectopic bone formation
  • At 12 months, fusion was achieved in 85.7% and 62.5% of patients in the low and high MPC treatment groups compared to 75% of patients who received bone autograft
  • Significant improvements in low back pain scores and total disability index were seen in both MPC groups and were comparable to those receiving bone autograft
  • Those receiving MPCs had 30-43% less blood loss during the surgical procedure than those receiving bone autograft (p less than 0.05)
  • These results indicate that lumbar vertebral fusion using allogeneic MPCs is as effective as bone autograft
  • Eliminating the need for an autograft bone harvest will avoid the risks of this procedure, including pain, infection and blood loss.

MELBOURNE, Australia, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (USOTC:MBLTY) today announced that its Phase 2 clinical trial for lumbar spinal fusion had successfully met its safety and efficacy endpoints. The results suggest that Mesoblast's NeoFuse product comprising allogeneic Mesenchymal Precursor Cells (MPCs) is as effective for interbody lumbar fusion as the gold standard, bone autograft, without the need for a second surgical procedure and its attendant morbidity risks. These results support the progression of clinical development of NeoFuse to a Phase 3 trial in interbody lumbar fusion. The results were highlighted during a presentation to the 31 st annual JP Morgan Healthcare Conference in San Francisco by Mesoblast Chief Executive Professor Silviu Itescu.   Twenty four (24) patients were enrolled and randomized over 5 sites in the United States with 8 patients in each treatment arm – bone autograft standard of care (Control), 25 million MPCs (25M), and 75 million MPCs (75M). Patients underwent the surgical procedure, one or two level fusions using a posterior approach to the spine, and were evaluated for safety and efficacy. The median follow-up times for the three treatment groups were 23.9, 20.7, and 22.9 months for the bone autograft, 25M, and 75M groups, respectively.   MPCs were well tolerated with no cell-related serious adverse events and no ectopic bone formation at all. Notably, MPC treated groups had 30-43% lower mean estimated blood loss during surgery compared to the autograft treatment group (p less than 0.05 for the 25M group).   At 12 months, fusion was achieved in 85.7% of patients in the 25M treatment group compared to 62.5% in the 75M and 75% in the control patient groups. Overall, patients from all three treatment groups had a clinically significant and comparable decrease in low back and leg pain, assessed on the Visual Analogue Scale and functional improvement, assessed by the Oswestry Disability Index questionnaire.   Dr Randall Dryer, an orthopedic surgeon with the Central Texas Spine Institute and an investigator in Mesoblast's study, said: "For patients whose spinal discs have degenerated too extensively for repair, bony fusion of adjacent vertebra is the primary option to eliminate chronic and debilitating pain.   "Other than autograft, there is no approved product for posterior spinal fusion, a surgical approach which accounts for 62% of all lumbar fusion procedures. There is a critical unmet need for new technologies to achieve fusion that are safe, effective, and that eliminate the need for bone autograft.   "Based upon my experience in the Phase 2 study, Mesoblast's cells may provide a significant and valuable option to achieve fusion in patients with severe spinal disc degeneration and these results warrant progressing to a Phase 3 study," Dr Dryer added.   According to Millennium Research Group, in the United States there were approximately 380,000 lumbar spinal fusion procedures performed in 2012. They estimate the overall worldwide market for bone graft substitutes to be nearly $1.6 billion dollars in 2012 with the majority of bone graft revenues, approximately 70%, coming from spinal fusion procedures.   Mesoblast plans to initiate a Phase 3 trial for interbody lumbar fusion later this year, with patients to be enrolled across multiple sites in the United States, Europe and Australia.   Mesoblast Limited

1 of 2

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 18,053.71 +23.50 0.13%
S&P 500 2,088.77 +6.89 0.33%
NASDAQ 4,806.8590 +33.3870 0.70%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs