Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis

Phase 2

Completed

• Conditions: Severe Osteoporosis
• Interventions: Drug: PREOB® Intravenous Infusion

• Registration Number: NCT02061995
• Lead Sponsor: Erasme University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of severe osteoporosis
• Non-response to anti-osteoporotic treatment for over 2 years
• Normal hematology function
• Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements

Exclusion Criteria

• Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1
• Current or past medical disease that could interfere with the evaluation of the efficacy, as judged by the investigator
• Severe renal or hepatic impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PREOB® Intravenous Infusion	PREOB® Intravenous Infusion	-

Primary Outcome Measures

Name	Time	Method
Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements	12 months
Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan	72 hours

Secondary Outcome Measures

Name	Time	Method
Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA)	12 months
Measurement of bone formation and resorption markers	12 months
Well-being score using SF-36 questionnaire	12 months
Occurrence of new vertebral fractures as assessed by X-ray	12 months
Pain measured by the Visual Analogue Scale	12 months

Trial Locations

Locations (1)

Investigating site BE01; 🇧🇪 Anderlecht, Belgium