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

NCT ID: NCT02061995

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-10-31

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.

Conditions

Severe Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PREOB® Intravenous Infusion

Group Type: EXPERIMENTAL

PREOB® Intravenous Infusion

Intervention Type: DRUG

Each patient will undergo a single intravenous administration of PREOB®.

Interventions

PREOB® Intravenous Infusion

Each patient will undergo a single intravenous administration of PREOB®.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigating site BE01

Anderlecht, , Belgium

Countries

Belgium

Other Identifiers

PREOB-OP1

Identifier Type: -

Identifier Source: org_study_id