Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis
|ClinicalTrials.gov Identifier: NCT02061995|
Recruitment Status : Unknown
Verified February 2014 by Erasme University Hospital.
Recruitment status was: Recruiting
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Osteoporosis||Drug: PREOB® Intravenous Infusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
|Experimental: PREOB® Intravenous Infusion||
Drug: PREOB® Intravenous Infusion
Each patient will undergo a single intravenous administration of PREOB®.
- Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan [ Time Frame: 72 hours ]
- Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements [ Time Frame: 12 months ]
- Pain measured by the Visual Analogue Scale [ Time Frame: 12 months ]
- Well-being score using SF-36 questionnaire [ Time Frame: 12 months ]
- Occurrence of new vertebral fractures as assessed by X-ray [ Time Frame: 12 months ]
- Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA) [ Time Frame: 12 months ]
- Measurement of bone formation and resorption markers [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061995
|Contact: Valérie Gangji, MD, PhDfirstname.lastname@example.org|
|Investigating site BE01||Recruiting|