Date: 2015-03-23
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Bone Therapeutics (Belgium)
Product: ALLOB®
Action
mechanism: cell therapy. ALLOB® is an allogeneic, differentiated osteoblastic cell therapy product developed for the treatment of orthopaedic conditions. Allogeneic cell therapy involves the harvesting of cells from a healthy, universal donor, rather than from the patient being treated. ALLOB® has shown safety and efficacy in preclinical studies and does not require any immunosuppressive side therapy.
Disease: degenerative lumbar disc disease
Therapeutic area: Bone diseases - Regenerative medicine
Country: Belgium
Trial details:
Latest
news: * On March 23, 2015, Bone Therapeutics, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, announced that the first four patients in the phase IIA proof-of-concept study for spinal fusion procedures have been treated with Bone Therapeutics’ allogeneic osteoblastic (bone-forming) cell therapy product, ALLOB®. This pilot Phase IIA study will enrol 16 patients with symptomatic degenerative lumbar disc disease who require interbody fusion surgery*. Patients will be treated with a single dose of ALLOB® combined with bioceramic granules to achieve bone formation and fusion of the vertebral bodies. Safety and efficacy of this treatment will be assessed over 12 months, using clinical and radiological evaluation. Spinal fusion is a procedure that eliminates pain and restores the normal life of a patient but, despite being a fairly routine surgery, is often associated with high failure rates. Bone Therapeutics’ cell therapy product has been designed to accelerate the fusion process and reduce the failure rate of current surgeries. Today, the procedure has been performed in four patients without any complications or safety issues. The trial is currently running in four centres across Belgium: the Erasmus Hospital in Brussels, the University Hospital of Charleroi, Brugmann University Hospital in Brussels and the Hospital Oost-Limburg in Genk. ALLOB® is also currently being studied in a Phase I/IIA trial for the treatment of delayed-union fractures and recently reported excellent safety and efficacy from the treatment of the initial four patients. * On September 15, 2014, Bone Therapeutics announced that it has received clearance from the Competent Authorities and Central Ethics Committee in Belgium for a phase II proof-of-concept study to assess safety and efficacy of its allogeneic osteoblastic cell therapy product ALLOB® in spinal fusion procedures for degenerative lumbar disc disease. Bone Therapeutics aims to investigate ALLOB®’s potential to fulfil this unmet medical need and improve spinal fusion surgery outcomes. ALLOB® has already shown the required osteoinductive, osteogenic and osteoconductive features2 for bone formation enhancement as well as excellent safety and efficacy in preclinical studies and is currently being evaluated in a phase I/IIa trial for delayed-union fractures.
In this pilot proof-of-concept study, 16 patients with symptomatic degenerative lumbar disc disease that require interbody fusion will be treated with a single dose of ALLOB® mixed with bioceramic granules to promote bone formation and fusion at the degenerative disc level.
The use of a bioceramic scaffold mixed with ALLOB® cells is intended to promote bone formation by (i) providing biologically active osteoblastic cells, (ii) restoring a healthy bone environment, and (iii) guiding growth in 3-dimensions. Patients will be enrolled in 4 centres and safety and efficacy of the treatment will be monitored over 12 months by clinical (Oswestry Disability Index) and radiological (fusion progression) evaluation, with an additional 24-month post-study follow-up.
