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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Erasme University Hospital
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT02061995
First received: February 11, 2014
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Severe Osteoporosis
Drug: PREOB® Intravenous Infusion
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain measured by the Visual Analogue Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Well-being score using SF-36 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence of new vertebral fractures as assessed by X-ray [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measurement of bone formation and resorption markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PREOB® Intravenous Infusion Drug: PREOB® Intravenous Infusion
Each patient will undergo a single intravenous administration of PREOB®.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061995

Contacts
Contact: Valérie Gangji, MD, PhD valerie.gangji@erasme.ulb.ac.be

Locations
Belgium
Investigating site BE01 Recruiting
Anderlecht, Belgium
Sponsors and Collaborators
Erasme University Hospital
  More Information

No publications provided

Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT02061995     History of Changes
Other Study ID Numbers: PREOB-OP1
Study First Received: February 11, 2014
Last Updated: February 12, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Erasme University Hospital:
Bone Diseases
Metabolic Bone Diseases
Osteoporosis
Bone Fractures
Osteoporotic Fractures
Musculoskeletal Diseases

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 15, 2014