amitava29 Apr 2009 04:31 pm
Biotechnology firm Mesoblast has received approval at Melbourne’s Epworth hospital to commence a Phase 2 trial of its allogeneic, or “off-the-shelf”, cell therapy product for fusion of the cervical spine.
Australian regenerative medicine company, Mesoblast Limited develops treatments for orthopaedic conditions, including an adult stem-cell technology aimed at the regeneration and repair of bone and cartilage.
InĀ phase I trials which was recently completed at Australia’s Monash University, Mesoblast’s allogeneic cells resulted in earlier and more robust fusion of the cervical spine than autograft, without any adverse events.
In phase II a 24-patient randomised, controlled trial will compare the safety and effectiveness of Mesoblast’s product NeoFuse(TM) against a procedure using a patient’s own hipbone (autograft).
The trial will compare the safety and effectiveness of Mesoblast’s product, NeoFuse, against a fusion procedure using a patient’s own hipbone.
Presently Mesoblast is looking forward to progress through necessary clinical trials and international regulatory processesĀ to commercialise the technology in as early as possible. cervical fusion represented a major, new market opportunity for the treatment of spinal diseases, which include spinal fusion of the lumbar (the lower back) and cervical (neck) vertebrae for end-stage degenerative intervertebral disc disease, and repair/regeneration of the discs for patients with earlier stage disease.
Source: news.com.au
Filed under Adult Stem Cell, New study, Spinal Cord Injury, Sports Injury, Stem Cell, Tendon Injury, bone injury | Comment Below
Related?
Stem Cell Tranasplant for Chemo-Radiation Therapy or Chemotherapy Recovery: Phase I Clinical Trial CompletedJuly 24th, 2006 ViaCell, Inc. today announced that it has enrolled and treated the last patient in the CB001 Phase I clinical trial and has begun the 100-day post-transplant follow-up.
Stem Cell Trial for Heart Attack Approved by FDAMay 7th, 2007 Australia's adult stem cell company, Mesoblast Limited has announced that the United States Food and Drug Administration (US FDA) has cleared the Investigational New Drug Submission (IND) of its US-based sister company,
Angioblast Systems Inc., to commence a Phase 2 clinical trial of its allogeneic, or 'off-the-shelf', adult stem cells for patients with heart attacks. The Phase 2 clinical trial will be based at the Texas Heart Institute, and will follow a similar protocol to the one used by the same investigators in preclinical studies for the IND submission.
World-First Australian Stem Cell Trial to Treat Degenerative Spinal Disease Wins FDA ApprovalDecember 20th, 2006 A world-first Australian medical therapy that uses stem cells to treat degenerative spinal disease has been approved for testing on patients in the US. Its preliminary animal trials were so promising that the US Food and Drug Administration allowed it to skip the small phase-one human safety trial and move straight into a larger phase-two trial.
Italy to setup Major Stem Cell Research Center by 2006September 13th, 2005 The center in Pisa is being promoted by the College of Medicine at the University of Pisa and will oversee the creation of a department for the clinical use of stem cells and one for research in biotechnology. It is backed by the regional government of Tuscany which is providing an initial five million euros.
Stem Cell Clinical Trial for Heart Attack Patients Reaches Safety MilestoneNovember 6th, 2005 Osiris Therapeutics, Inc. announced today that its multi-center, human clinical stem cell trial for the treatment of patients suffering from heart attacks has successfully passed the first safety milestone of the trial.
Stem cell therapy can reverse severe heart blockages and limb ischemiaApril 22nd, 2009 TCA Cellular Therapy, a small Covington laboratory came into lime light by initiating significant break through in stem cell therapy. It is claimed that they have successfully treated heart disease and limb ischemia through adult stem cell therapy.
Stem Cell Product Trial to Treat Heart Attack Receives FDA Clearance May 10th, 2007 Australia's adult stem cell company, Mesoblast Limited has announced that the United States Food and Drug Administration (US FDA) has cleared the Investigational New Drug Submission (IND) of its US-based sister company, Angioblast Systems Inc., to commence a Phase 2 clinical trial of its allogeneic, or 'off-the-shelf', adult stem cells for patients with heart attacks. The Phase 2 clinical trial will be based at the Texas Heart Institute, and will follow a similar protocol to the one used by the same investigators in preclinical studies for the IND submission.
Children With Rare Neurogenerative Disorder Will Undergo Phase I Clinical Trial Using Stem CellsMarch 16th, 2006 Children and infants with a rare neurodegenerative disorder, will undergo a Phase I clinical trial using stem cells at Doernbecher Children's Hospital, Oregon Health & Science University. This trial will test if:
1.
Leave a Comment