Just from the title of this one I would think this trial could possibly fill up pretty quickly.  I just about can’t think of anyone who would want to pass up trying a stem cell treatment before an extensive surgical procedure on your back. 

Mesoblast's Heart Stem Cell Treatment to Rebuild Blood Vessels and Heart Muscles Has Positive Results–Regenerative Medicineimage

The company also has some good results showing that the Revascor treatment reduced the number of patients who developed any major heart failures from 40% to 6.7%, and those are substantial numbers.  Mesoblast is located in Australia.  The company also has other areas of regenerative medicine with bone regrowth and they are working on developing a product for direct injection into a diseased artery at the time of the angioplasty to increase the likelihood of long term survival of the limb.

From the website:

“For patients whose discs have degenerated too extensively for repair, bony fusion is the only viable option to eliminate pain. Mesoblast is in clinical trials with its bone fusion product NeoFuse™, in minimally invasive surgery for fusion of the spine.

Positive and well tolerated outcomes are expected to enable the company to compete effectively in the United States market where over 500,000 fusion procedures are performed annually. Currently BMP-2 marketed by Medtronic is a biologic that has approximately $1B/year in sales, however its market share is primarily attributed to off-label usage and has more recently been associated with a number of FDA safety warnings suggesting an opportunity for Mesoblast’s MPCs to quickly gain market share if superior and safer outcomes result from the clinical studies.”

MELBOURNE (Dow Jones)--Australian regenerative medicine company Mesoblast Ltd. (MSB.AU) said Wednesday it has been cleared by the U.S. Food & Drug Administration to begin an advanced clinical trial of its stem cell product to treat chronic low back pain.

The company said in a statement the Phase 2 trial would build on pre-clinical results that showed that degeneration of damaged intervertebral discs reversed, disc cartilage regrew and function was normalized six months after a low-dose injection of its regeneration product.

"There is a clear need for a product to reverse the degenerative process and regenerate the disc back to a healthy state," chief executive Silviu Itescu said.

"We believe our allogeneic adult stem cell product may represent a major breakthrough into this unmet market segment."

Mesoblast Cleared By FDA For Advanced Trials Of Back Pain Treatment - WSJ.com


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