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Bone Therapeutics

Ongoing studies

Clinical studies are currently being conducted with the aim of evaluating the safety and efficacy of enriched intra-articular injectable protein solution JTA-004 and products from the allogeneic cell therapy platform ALLOB in different indications:

 

Knee Osteoarthritis

The JTA-004 knee osteoarthritis phase III study is a controlled, randomized, double-blind trial. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee at 3 months compared to placebo or Hylan G-F 20, a leading osteoarthritis treatment on the market. In the study, 676 patients with mild to moderate symptomatic knee osteoarthritis are expected to be enrolled. The study will be conducted in approximately 20 centers in six European countries as well as Hong Kong SAR.

Study status : Recruiting

Population : Males and females 40 years and older with moderate symptomatic knee osteoarthritis (Kellgren-Lawrence Grade II and III).

Sites : Investigating sites currently recruiting in Hong Kong SAR and Denmark

Detailed information : Further information on the study can be found at ClinicalTrials.gov ( NCT04333160 )

 

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 : Finalised

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

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 : Finalised

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.

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