Mesoblast stem cell trial gets ethics approval

Adult stem cell specialist Mesoblast (ASX:MSB) has received ethics approval to commence its first human orthopaedic trial.

The Royal Melbourne Hospital's Human Research Ethics Committee has approved a pilot trial of up to ten patients suffering from non-union of long bone fractures to test safety of Mesoblast's adult stem cell technology.

Mesoblast uses proprietary technology to extract purified mesenchymal precursor cells from bone marrow.

"They're cultured into a significant number of batches that can be frozen and immediately available at any point in time to an orthopaedic surgeon who undertakes a surgical procedure to repair a broken bone," said Mesoblast executive chairman Michael Spooner.

The expanded stem cells are then implanted into the affected area of each patient.

"Preclinical studies have already shown that Mesoblast's specialist adult stem cell technology can generate new bone growth and new blood vessels. Both these outcomes appear to occur rapidly without the need for additional surgical procedures and painful bone grafts," said the pilot trial's principal medical investigator Prof Stephen in a statement.

Recruitment of the first patients is anticipated in the near future and the clinical trial is expected to commence in around eight to ten weeks. This includes a period of time for harvesting, culturing and expanding the patients' own stem cells at the Peter MacCallum Cancer Institute's cell therapies department, under Good Manufacturing Practice (GMP) conditions.

"We ultimately see this as being a product that's commercially available, that provides a regenerative process to heal a bone and for those patients to regain mobility, not have the pain they have, and having full function of their affected limbs," said Spooner.

Mesoblast has already received ethics approval for a phase I human trial at Newcastle's John Hunter Hospital for patients with multi-coronary vessel disease which is expected to commence in eight to ten weeks as well, said Spooner. A series of large animal dose-escalation studies for long bone fractures and intervertebral spinal fusion is also underway at the Colorado State University, USA.