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Clinical Trials/EUCTR2009-012929-11-GB
EUCTR2009-012929-11-GBActive, not recruitingPhase 1

Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head - PREOB-ON3

Bone Therapeutics S.A.0 sites68 target enrollmentStarted: November 19, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
68
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Men or women between 18 and 70 years (inclusive)
  • •2. Ability to provide a written, dated, and signed informed consent prior to any study related procedure and to understand and comply with study requirements
  • •3.Diagnosis of Osteonecrosis:
  • •a.ARCO stage I associated with WOMAC® VA3.1 pain score =20 mm and necrotic angle sum =190° based on sagittal and coronal MRI views
  • •b.ARCO stage II associated with WOMAC® VA3.1 pain score =20 mm if necrotic angle sum <190°
  • •based on sagittal and coronal MRI views
  • •c.ARCO stage II associated or not with pain if necrotic angle sum is =190° based on sagittal and coronal MRI views
  • •d.Associated with corticosteroid and/or with alcohol abuse and/or idiopathic.
  • •4.Normal haematology function, defined as: leukocytes =3000/mm3, absolute neutrophils count =1500/mm3, platelets =140,000/mm3, and haemoglobin concentration =10g/dl (peripheral blood test)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 100
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

  • •1.Exclusively diaphyseal or metaphyseal osteonecrotic lesion
  • •2.Traumatic or hyperbaric osteonecrosis, or osteonecrosis associated with hemoglobinopathy or coagulopathy (e.g., thalassemia, sickle cell disease,…), or Gaucher’s disease
  • •3.Osteoarthritis at the hip under evaluation defined as Kellgrens stage =2, as assessed by the Central Radiologist
  • •4.Patients suffering from any medical conditions interfering with patient’s pain evaluation of the hip under evaluation, such as knee arthritis.
  • •5.Bone fracture or bone infection at hip under evaluation.
  • •6.Patients who are candidates for any predictable joint replacement on the hip that is evaluated
  • •7.Blood not qualifying for PREOB® production, including active hepatitis B (defined as positive HBs Ag and/or positive PCR), or active hepatitis C (defined as positive PCR), positive serology for HIV, or Syphilis, or HTLV-1, and any other tests that may be required by the authorities in case of a new disease outbreak that can affect the safety of the physicians and operators at the time of patient screening.
  • •8.Presence, or previous history, of risks factors for diseases caused by prions, and recipients of grafts of cornea, sclera, and dura mater
  • •9.History of blood loss exceeding 450 ml (incl. donations) within 1 month of screening
  • •10.Renal impairment defined by an estimated creatinine clearance value < 30 ml per min, calculated with the Cockcroft-Gault formula
  • •11.Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase = 3 times the upper limit of normal
  • •12.Poorly controlled diabetes mellitus, defined as HbA1C > 9%
  • •13.Global sepsis
  • •14.Allergy to gentamicin or any substance or device the patient might be exposed to in the context of the study related interventions (i.e., bone marrow harvesting and implantation), as judged by the Investigator
  • •15. History of hypersensitivity to human biological material, including blood and blood derived products, documented clinically or by laboratory tests
  • •16.Current or past history of solid or haematological neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence)
  • •17.History of bone marrow transplantation
  • •18.Patients with a life expectancy less than 2 years, as judged by the Investigator
  • •19.Patients treated by core decompression of the hip under evaluation within 6 months of screening
  • •20.Treatment with doses of prednisolone =15 mg per day (or equivalent) within 1 month from screening, and patients with anticipated needs of daily corticoid doses =15 mg prednisone (or equivalent) in the 6-month period following PREOB®/Placebo implantation
  • •21.Illicit drug or alcohol abuse interfering with patient’s ability to understand and comply with study requirements, as judged by the Investigator
  • •22.Pregnancy
  • •23.Breast-feeding
  • •24.Patients unable to undergo MRI, e.g. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves

Investigators

Sponsor
Bone Therapeutics S.A.

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