Bone Therapeutics gets approval for pivotal phase III osteonecrosis trial in Europe and treats first patients with their Advanced Therapy Medicinal Product PREOB®

After receiving clearance from the competent authorities in Europe for its phase III pivotal osteonecrosis* trial with their second generation Advanced Therapy Medicinal Product (ATMP), PREOB®, bone regenerative medicine company Bone Therapeutics recently announced that their phase III trial has gotten underway with the first patients in the study.

Specializing in the treatment of osteo-articular diseases using cell therapy, Bone Therapeutics has developed an innovative cell product that will focus on the repair and regeneration of the hip in efforts to treat a disease known as osteonecrosis. Previous trial results with their innovative cell therapy product have shown it has the ability to stop and even reverse the progression of osteonecrosis for which there is currently no conservative treatment. The trial is currently being tested among 130 patients with early stage osteonecrosis throughout 20 to 25 centers in Europe. In its first double-blind trial of its class, patients have been randomly selected to receive either the cell therapy product or a placebo in a double-blind, controlled study format. The autologous bone cell medicinal product is administered via a minimally invasive approach, percutaneously, meaning through the skin, therefore preventing the need for surgery. The trial is aiming to reproduce the positive pilot trial results in which administration of their cell therapy product effectively managed to halt or revert disease progression as well as significantly reduce pain and improve hip function in patients with early stage osteonecrosis, compared to that of the reference group.

With support from the Walloon Region and its investors, Bone Therapeutics’ teams are achieving significant advancements in such cell therapy developments and clearance for this trial is yet another milestone further validating their clinical, regulatory and manufacturing capabilities. The company is also working in close collaboration with the rheumatology department of Erasme University Hospital (ULB, Brussels, Belgium) and the rheumatology department of CHU Sart-Tilman Hospital (ULg, Liège, Belgium).

This pivotal phase III trial could be a significant step towards bringing adult derived-stem cell therapeutics closer to the market, allowing easier accessibility to patients suffering from such severe, debilitating diseases. Currently being developed under an orphan drug designation granted both in Europe and in the USA, PREOB® will be the first conservative treatment for this type of indication. Should all go as expected, the trial underway is anticipated to be the final phase of testing before obtaining the necessary approval for commercialization in Europe.

* Osteonecrosis is a painful and devastating disorder of the hip, affecting young patients 30-50 years of age, which leads to femoral head collapse and total hip replacement within 2 years. There are over 200,000 new cases in Europe and North America per year.

Note: Bone Therapeutics portfolio of cell therapy products includes PREOB® currently in phase III pivotal trials in Europe, ALLOB®, an allogeneic bone cell product and MXB, a matrix-embedded cell product.




Bone Therapeutics S.A.
Rue Adrienne Bolland, 8
6041 Gosselies – Belgium (Europe)
Phone: +32 (0) 2 529 59 90
Fax: +32 (0) 2 529 59 93

Enrico Bastianelli – CEO
Tel: +32 (0)2 529 59 90

Ingrid Bourges – PhD – Manager – Scientific and Business Administration  –
Tel: +32 2 529 58 66

Valérie Roels – Office & Communication Manager
Tel: + 32 2 529 59 90

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