First patients treated in pioneering trial for treatment of failed spinal fusion
Bone Therapeutics, the bone cell therapy company, has announced that it has treated the first patients suffering from a failed spinal fusion with its unique allogeneic bone cell therapy product ALLOB®.
This is the first trial involving the administration of a bone cell therapy product percutaneously directly into the failed fusion area without an open procedure. The implantation of bone cells is intended to promote the fusion process through stimulation of bone formation. This study complements the key Phase IIA ALLOB spinal fusion trial that was initiated last year.
Around one million spinal fusion procedures are performed each year in Europe and the USA. For the lumbar spine, which accounts for half a million fusion procedures annually, non-union and failure to relieve lower back pain are still frequent outcomes. It is estimated that up to one-quarter of spinal fusion procedures are unsuccessful [1]. Standard of care revision procedures require open surgery and are associated with several factors that present more difficulties than the initial surgery, consequently increasing the risk of complications [2]. For example, fibrosis and scarring make revision surgery significantly more difficult and vascular supply may be compromised [3]. Bone Therapeutics’ rescue procedure is designed to be safer and easier compared with the existing procedures.
The study is a pilot, open, proof-of-concept Phase IIA trial to evaluate the safety and the efficacy of ALLOB implantation in rescue spinal fusion over 12 months. Sixteen patients diagnosed with a failed lumbar spinal fusion at 15 months or more following the initial surgery, and requiring a rescue surgery, will be treated with a single percutaneous implantation of ALLOB cells into the failed fusion area. The process is monitored by fluoroscopy to visualise and optimise the exact location of administration. The efficacy of the treatment will be evaluated clinically and radiologically by CT-scan.
Enrico Bastianelli, CEO of Bone Therapeutics, said: “We are delighted to start this pioneering rescue spinal fusion trial alongside the two other Phase II trials for ALLOB that were initiated last year. With this trial we are aiming to offer a safe and minimally invasive treatment option to patients who are suffering from a failed spinal fusion. The trial is a key pillar of Bone Therapeutics’ strategy to leverage our unique bone cell platform, accelerate Phase II clinical trials specifically in spinal fusion procedures and further develop an advanced and diversified product pipeline.”
Source: Business Wire
References
Nguyen et al. Epidemiology. 2011 (36)320-331; Aghion et al. Med Health R I. 2012 (95)391-393
Ma et al. Spine J. 2010 (10)881-9
Eichholz et al. Neurosurg Focus. 2003 (15)3
