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Bone Therapeutics

Ongoing studies

 

Clinical studies are currently being conducted with the aim of evaluating the safety and efficacy of the PREOB® and ALLOB® cell therapy products in different indications:

 

Osteonecrosis of the hip

A phase III study is evaluating the safety and efficacy of administering autologous osteoblastic cells (PREOB®) to patients with early-stage osteonecrosis of the femoral head of the hip versus placebo. Early-stage corresponds to the stage of the disease before the femoral head shows radiological signs of fracture.

More specifically, two treatments are compared:

  1. the combination of core decompression* and PREOB® implantation into the necrotic lesion, and
  2. the combination of core decompression* and placebo implantation into the necrotic lesion.

* Core decompression is an internal drilling of the femoral head and neck. This procedure decompresses the femoral head and reduces pain.

The aim of the study is to show that PREOB® is an effective treatment in relieving symptoms and halting the progression of the radiological lesions of the disease.

Study status: Recruitment in progress

Population: Men and women aged between 18 and 70 years with ARCO stage I or II osteonecrosis of the hip.

Sites: Research sites across Belgium, France, Germany, the Netherlands and the United Kingdom.

Participation: More information on this subject can be found on the page relating to participation in a clinical study.

Detailed information: Further information on the study can be found at clinicaltrials.gov/ct2/show/NCT01529008

 

Non-union fractures

A phase IIB/III study is evaluating the safety and efficacy of administering autologous osteoblastic cells (PREOB®) in the treatment of non-union fractures.

In this study, the patients are randomly assigned to receive either a single percutaneous injection of PREOB® or a bone autograft (current standard of care). The study is evaluating the non-inferiority of the minimally invasive injection of a single dose of PREOB® compared to the standard highly invasive treatment of a bone autograft.

Study status: Recruitment in progress

Population: Men and women aged between 18 and 65 years with a non-union fracture of a long bone that is at least six months old.

Sites: The investigating sites are in Belgium.

Participation: More information on this subject can be found on the page relating to participation in a clinical study.

Detailed information: Further information on the study can be found at clinicaltrials.gov/ct2/show/NCT01756326

 

Delayed-union fractures

A phase I/IIA study is evaluating the safety and efficacy of administering allogeneic osteoblastic cells (ALLOB®) in the treatment of delayed-union fractures.

The study involves patients with a fracture that has not healed after three to seven months. These patients will receive percutaneous administration of the product ALLOB® directly into the fracture site. The aim of this study is to examine the safety of ALLOB® and offer treatment to this group of patients who are currently generally not treated.

Study status: Recruitment in progress

Population: Males and females aged between 18 and 70 years with a non-union fracture of a long bone which is at least three months and at most seven months old.

Sites: Investigating sites across Belgium and Germany

Participation: More information on this subject can be found on the page relating to participation in a clinical study.

Detailed information: Further information on the study can be found at clinicaltrials.gov/ct2/show/NCT02020590

 

Spinal fusion procedures

A phase IIA study is evaluating the safety and efficacy of administering allogeneic osteoblastic cells (ALLOB®) in lumbar spinal fusion: a surgical procedure which consists of fusing one or more painful vertebrae of the lumbar spine.

The study includes patients with symptomatic degenerative disc disease requiring a single-level lumbar spinal fusion. An interbody fusion cage is implanted, in accordance with the standard of care for the surgical approach, and a mix of ALLOB® product and β-TCP granules is inserted into it. The combination of osteoblastic cells and a synthetic scaffold is designed to deliver biologically active bone cells, restore a healthy environment for cell proliferation and development and enable 3D bone formation. This approach aims to reduce the number of spinal fusion failures and thus prevent another procedure.

Study status: Recruitment in progress

Population: Men and women aged between 18 and 75 years with symptomatic degenerative disc disease requiring a single-level lumbar spinal fusion and unresponsive to non-operative treatment for at least the past six months.

Sites: The investigating sites are in Belgium.

Participation: More information on this subject can be found on the page relating to participation in a clinical study.

Detailed information: Further information on the study can be found at clinicaltrials.gov/ct2/show/NCT02205138

 

Revision spinal fusion

A phase IIA study is evaluating the safety and efficacy of osteoblastic cell implantation (ALLOB®) in revision lumbar spinal fusion surgery.

Sixteen patients with spinal fusion failure, who underwent initial surgery at least fifteen months ago and require revision surgery, are being treated with a single percutaneous administration of ALLOB® cells into the failed fusion level.

Study status: Recruitment in progress

Population: Men and women aged at least 18 years, whose first spinal fusion failed after at least 15 months requiring revision surgery.

Site: The investigating sites are in Belgium.

Participation: More information on this subject can be found on the page relating to participation in a clinical study.

Detailed information: Further information on the study can be found at clinicaltrials.gov/ct2/show/NCT02328287