Date: 2013-11-02
Type of information: Treatment of the first patient
phase: 2b-3
Announcement: treatment of the first patient
Company: Bone Therapeutics (Belgium)
Product: PREOB®
Action
mechanism: cell therapy. PREOB® is a cell therapy product. PREOB® is a first-in-class autologous osteoblastic/bone forming cell product. It is positioned as a first-line treatment for non-union fractures as it is administered via a minimally invasive approach directly into the fracture site, thereby avoiding the need for open surgery.
Disease: non-union fractures
Therapeutic area: Bone diseases - Regenerative medicine
Country: Belgium, France, the Netherlands
Trial
details: The pivotal Phase IIb/III, multicentre, randomised, open-controlled study will determine the efficacy and safety of PREOB® in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to bone autograft in a non-inferiority design including a 12 month follow-up. 176 patients will be randomized in two groups in a 1:1 ratio (88 patients in the PREOB® group vs. 88 patients in the bone autograft group).
Efficacy and safety will be checked at each scheduled visit over the 12 month follow-up period for all patients using clinical (i.e., pain and function) and radiological evaluation. An interim analysis is planned at the midpoint of the study.
Latest
news: *On November 26, 2013, Bone Therapeutics, a Belgian regenerative therapy company addressing unmet needs in the field of orthopaedics via a minimally invasive approach, has announcesd it has received clearance from the Competent Authorities in Belgium, France and the Netherlands to initiate a phase IIb/III trial with its autologous cell therapy product, PREOB®, for the treatment of non-union fractures. First patients have already been treated in Belgium. PREOB® is also being evaluated in an ongoing Phase III trial for the treatment of osteonecrosis.
