In short
Regenerative medicine specialist company Mesoblast Limited is sounding bullish about its stem cell treatment for adult intervertebral disc disease with the announcement that its clinical trial is progressing rapidly. The phase 2 trial is investigating the use of allogeneic, or off-the-shelf, Mesenchymal Precursor Cells (MPCs) for non-surgical restoration of degenerated intervertebral discs and treatment of low back pain, and has enrolled 50% of its total study patients. The company attests this rapid rate of enrolment to the major unmet medical need and to the relative simplicity of Mesoblast’s non-surgical procedure. Mesoblast expects to complete full enrolment by early third quarter.
Background
Up to 15 per cent of people in industrialised countries have chronic low back pain lasting more than six months. For those with progressive, severe and debilitating pain due to degenerating intervertebral discs, the only current option is major back surgery involving spinal fusion, artificial disc replacement, or other surgical procedures. Avoidance of surgery and its complications is a major objective of any new treatment for degenerative disease of the spine.
Mesoblast is developing a non-surgical adult stem cell treatment for these patients using a simple intervertebral disc injection of allogeneic MPCs that takes less than 15 minutes in an outpatient setting. The Phase 2 clinical trial design, endpoints and dose ranges are based on Mesoblast’s successful preclinical study using allogeneic sheep MPCs for non-surgical restoration of damaged intervertebral discs. That study, published in the peer-reviewed Journal of Neurosurgery showed that a single non-surgical injection of Mesoblast’s allogeneic MPCs into damaged intervertebral discs resulted in significant regeneration of disc anatomy, increase in proteoglycan content, and increase in disc height, for at least six months.
The study
Mesoblast’s double-blind, placebo-controlled Phase 2 clinical trial is being conducted at 15 sites across the United States, and will randomise a total of 100 patients with intervertebral disc disease to receive a non-surgical, percutaneous injection into the intervertebral disc of either low or high dose MPCs with hyaluronic acid carrier, hyaluronic acid carrier alone or saline alone. The trial aims to extend Mesoblast’s preclinical results, and show that a single MPC injection can reduce low back pain and improve function over six months, improve disc anatomy, and eliminate the need for a surgical procedure.
Source: Mesoblast Ltd, PR Newswire
published: April 18, 2012 in: Clinical Studies/Trials, Spine