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

Severe Osteoporosis Clinical Trial

Official title:

Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061995
• Other study ID #: PREOB-OP1
• Status: Completed
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: October 2016

Study information

• Verified date: February 2014
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Severe Osteoporosis

Intervention

Drug:
• PREOB® Intravenous Infusion
Each patient will undergo a single intravenous administration of PREOB®.

Locations

Country	Name	City	State
Belgium	Investigating site BE01	Anderlecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan		72 hours
Primary	Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements		12 months
Secondary	Pain measured by the Visual Analogue Scale		12 months
Secondary	Well-being score using SF-36 questionnaire		12 months
Secondary	Occurrence of new vertebral fractures as assessed by X-ray		12 months
Secondary	Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA)		12 months
Secondary	Measurement of bone formation and resorption markers		12 months