New cell therapy study begins for treatment of delayed union fractures in long bones
BONE THERAPEUTICS, the leading biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases, announces today that it has received clearance from the Competent Authorities in Belgium and the UK for a phase I/IIa trial with its allogeneic cell therapy product ALLOB® for the treatment of delayed union fractures.
ALLOB® is an allogeneic, osteoblastic (i.e. bone-forming) cell therapy product. ALLOB® has already shown safety and efficacy in preclinical studies and has the potential to become a first-line treatment for impaired fracture healing, thanks to its minimally invasive percutaneous administration, avoiding the need for surgery.
This first-in-human, proof-of-concept, phase I/IIa study is a 6 months open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed union fractures of long bones. Thirty-two patients will be enrolled in 10 centers. They will receive a single percutaneous administration of ALLOB® directly into the fracture site. ALLOB®-treated patients will be assessed in comparison to baseline at 2 weeks, 1, 3 and 6 months using clinical (e.g., pain, weight-bearing) and radiological evaluation.
Bone Therapeutics has already secured both ‘Tissue Establishment’ and ‘GMP’ Accreditation for the in-house manufacturing of ALLOB®. This not only allows Bone Therapeutics to have enhanced control over ALLOB®’s production, but secures the manufacturing runway for scale up of production to support ALLOB®’s further development.
Enrico Bastianelli, CEO of Bone Therapeutics commented, “This new clinical trial clearance from the Competent Authorities in Belgium and the UK is an important milestone in the development of ALLOB® and further validates Bone Therapeutics’ clinical, regulatory and manufacturing capabilities. The only way to address delayed union fractures currently is invasive surgery which could have severe complications and a long hospital stay. With ALLOB®’s bone regenerative mode of action and minimally invasive administration, Bone Therapeutics’ allogeneic product could become a first-line treatment.”
ALLOB® is Bone Therapeutics’ allogeneic bone cell therapy product. “Allogeneic” means that the cells are harvested from a healthy, universal donor, rather than from the patient (autologous). Currently in a Phase I/IIa clinical trial for delayed union fractures, ALLOB® also has the potential for systemic applications such as in osteogenesis imperfecta, a rare genetic bone disease characterized by bone fragility and fractures. ALLOB® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.
About delayed union fractures
A delayed union fracture is defined as a bone that has not healed within the expected normal period of time after the initial injury (i.e., 3 to 4 months) and is at risk of non-healing. Around one million patients are affected by delayed union each year. Traditional options for the treatment of impaired fracture healing typically involve highly invasive surgery, which can be painful and require months of rehabilitation with no guarantee of success.
 Where cells are derived from a healthy, universal donor, rather than the patient.
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