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Bone Therapeutics

Indications

Osteonecrosis of the hip

Osteonecrosis of the hip is a bone disease characterized by the death of bone cells, and the loss of associated marrow elements. It is a painful condition in which the joint degenerates progressively, ultimately leading to collapse of the femoral head, requiring a total hip replacement. Different stages of osteonecrosis can be distinguished of which stages I & II represent the stages before fracture and stages III & IV the stages after fracture. This condition typically affects relatively young people (30-60 years old, only 20% of patients are older than 50), where hip replacement is not appropriate due to the limited lifespan of the prosthesis. Unfortunately, due to the lack of alternative treatments, nearly 50% of patients will require a hip replacement before the age of 40. Core decompression is the most used therapeutic option for early-stage osteonecrosis: despite the highly variable reported success rates and a controversial efficacy, this surgical procedure is still considered as the standard of care.  

Bone Therapeutics' products have been designed as an effective add-on therapy to core decompression and will aim to improve established treatments. After core decompression, PREOB® (autologous bone marrow cells) is administered at the necrotic site in order to improve the bone structure by replacing the defective cells and by recreating a healty environment. This approach will preserve the minimally invasive character of the current standard of care whilst addressing the physiopathogenic mechanisms proposed for the disease.

Non-union fractures

Non-union fractures are characterized by a failure to achieve bone union within 6-9 months, as all reparative processes have ceased, hence requiring additional surgical intervention. Standard treatment options for non-union fractures typically involve highly invasive surgery (i.e., bone graft), which is painful, requires months of rehabilitation and has a considerable risk of serious complications. Side-effects related to bone autograft, the current standard-of-care, are considerable, with complications (pain at harvest site, infection) reported in 20% of patients. To date, this approach remains the gold-standard as it presents 75 to 85% efficacy and advantageously avoids risks of disease transmission.

Bone Therapeutics' cell therapy-based products are intended to become a first-line treatment for this indication. The products should be as efficacious as the current standard-of-care and superior in terms of patient safety (i.e., the minimally-invasive cell implantation would avoid open surgery and a long hospital stay and allow for a faster recovery).

Delayed-union fractures

A delayed-union fracture is defined as a fracture that has not healed within the expected normal period after the initial injury (i.e. 3 to 4 months) and is at risk of non-healing. Traditional options for the treatment of an impaired fracture (i.e. bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications. Due to the risks of current treatments, orthopaedic surgeons often take a ‘wait-and-see’ approach, sometimes for several months, which delays the patient’s return to a normal life and leads to a significant burden on society.

ALLOB® has the potential to become a first-line and early treatment for delayed-union fractures, thanks to its minimally invasive administration that avoids the need for major surgery.

Degenerative spine disorders : spinal fusion procedures

Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders, including degenerative disc disease, spondylolisthesis, scoliosis and stenosis, to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, – placed into the intervertebral space – for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Despite the fact that spinal fusion surgery is routine, non-union and failure to relieve lower back pain are unfortunately still frequent as up to 25 to 30% of spinal fusion patients are not completely satisfied with their surgery.

Bone Therapeutics' products are intended to decrease the failure rate of spinal fusion surgeries.

Degenerative spine disorders : revision spinal fusion

Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders, including degenerative disc disease, spondylolisthesis, scoliosis and stenosis, to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, – placed into the intervertebral space – for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Despite the fact that spinal fusion surgery is routine, non-union and failure to relieve lower back pain are unfortunately still frequent as up to 25 to 30% of spinal fusion patients are not completely satisfied with their surgery.

Bone Therapeutics' products are intended to decrease the failure rate of spinal fusion surgeries.

Severe osteoporosis

Osteoporosis is a progressive bone disease characterized by an excessive loss of bone mass leading to bone fragility and increased risk of fracture. Several anti-osteoporotic treatments exist of which most prevent bone resorption and do not induce bone formation. Osteoporosis remains a significant health problem for patients who do not respond to treatment or fail to comply with their drug regimens. Despite demonstrated efficacy, most available drugs are not fully satisfying due to safety issues (e.g., osteonecrosis of the jaw), intolerance to treatment and regimen inconvenience. Together with the 35% non-responding patients, these concerns motivate physicians to seek novel alternative treatments.

There is a significant opportunity for cell therapy-based products, such as the Bone Therapeutics' products, as last-line treatment for patients who do not respond to the available biologics or who fail to comply with their regimens.