Adult stem cell company Mesoblast has had filed an Investigational New Drug submission (IND) to the United States Food and Drug Administration (FDA) to commence a clinical trial of its allogeneic, or 'off-the-shelf', adult stem cells for spinal fusion.

The trial design will enable the evaluation of the safety and effectiveness of Mesoblast's stem cells in patients suffering degenerative intervertebral disc disease.

The trial will comprise three groups who will receive differing doses of stem cells - low, medium or high. A fourth group of patients will serve as controls and receive current standard-of-care spinal fusion treatment. Subject to FDA clearance, up to 60 patients will be recruited for the trial, which will start early next year.

A company spokesperson said the IND filing was an important milestone for Mesoblast, reached over six months ahead of schedule.

"It underscores the rapid progress that has been made over the past two years, and positions the company at an advanced stage of clinical development and product commercialisation," the spokesperson said.

Mesoblast's commercial strategy is to produce a high margin, unique adult stem cell product that is obtained from a single donor, commercially expanded and frozen, and subsequently used in hundreds to thousands of unrelated, or allogeneic, recipients at the time and place of need.

Over 300,000 spinal fusion procedures are currently performed annually in the US alone for patients with degenerative intervertebral disc disease, representing a rapidly growing, multi-billion dollar market. Current fusion therapies use bone harvested from a patient's own hip, called an autograft, and require a second surgical procedure that can result in long-term complications such as chronic pain and infection.

The spokesperson said that in preclinical studies, Mesoblast's allogeneic stem cells were well-tolerated and generated significantly superior spinal fusion compared with controls receiving the carrier alone. Fusion was at least equal or more robust, continuous, and mechanically strong when compared with hip bone autograft. Together with its sister company, US-based Angioblast Systems, Mesoblast is currently completing additional orthopaedic and cardiovascular IND submissions to the FDA.