Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Osteoporosis is a systemic skeletal disease characterized by low bone mass and
microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility
and susceptibility to fracture.
Osteoporosis is one of the most common and debilitating chronic diseases, and a global health
concern with a high prevalence not only in Western countries, but also in Asia and Latin
America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like
bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent.
Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass
and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black
et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of
pharmacological treatments, osteoporosis remains a significant health problem for patients
who do not respond to the available treatments or fail to comply with their regimens.
The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a
proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic
patients who do not respond to pharmacological treatments.