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Trial record 7 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Osteonecrosis"

Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head

This study is currently recruiting participants.
Verified October 2017 by Bone Therapeutics S.A
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529008
First Posted: February 8, 2012
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bone Therapeutics S.A
  Purpose

Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated.

The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment.

Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed.

This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is superior to core decompression/placebo implantation in relieving hip symptoms and halting (or reverting) radiological progression of the disease.


Condition Intervention Phase
Osteonecrosis of the Femoral Head Drug: Core decompression/PREOB® implantation Drug: Core decompression/placebo implantation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, 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

Resource links provided by NLM:


Further study details as provided by Bone Therapeutics S.A:

Primary Outcome Measures:
  • Percentage of treatment responders [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Percentage of treatment responders [ Time Frame: 6, 12, 18 and over 24 months follow-up period ]
  • Percentage of clinical responders [ Time Frame: 1, 3, 6, 12, 18, 24 and over 24 months follow-up period ]
  • percentage of radiological responders [ Time Frame: 6, 12, 18, 24 and over 24 months follow-up period ]
  • Absolute change from baseline in WOMAC VA1.3 total score [ Time Frame: 1, 3, 6, 12, 18, 24 and over 24 months follow-up period ]
  • Time to progression to fractural stage (ARCO III and higher) of the study treated hip [ Time Frame: 24 months ]
  • Time to hip arthroplasty [ Time Frame: 24 months ]
  • Percentage of patients requiring hip arthroplasty [ Time Frame: 1, 3, 6, 12, 18, 24 and over 24 months follow-up period ]
  • Absolute change from baseline in WOMAC VA1.3 composite pain subscale score [ Time Frame: 1, 3, 6, 12, 18, 24 and over 24 months follow-up period ]
  • Absolute change from baseline in WOMAC VA1.3 stiffness subscale score [ Time Frame: 1, 3, 6, 12, 18, 24 and over 24 months follow-up period ]
  • Absolute change from baseline in WOMAC VA1.3 functional subscale score [ Time Frame: 1, 3, 6, 12, 18, 24 and over 24 months follow-up period ]

Estimated Enrollment: 118
Study Start Date: November 2011
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Core decompression/PREOB® implantation Drug: Core decompression/PREOB® implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
Placebo Comparator: Core decompression/placebo implantation Drug: Core decompression/placebo implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women between 18 and 70 years (inclusive) with a diagnosis of ARCO Stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by central imaging analysis based on X-ray and MRI.
  • Ability to provide a written, dated, and signed informed consent prior to any study related procedure and to understand and comply with study requirements
  • Diagnosis of Osteonecrosis:

    1. ARCO stage I associated with WOMAC® VA3.1 pain score ≥20 mm and necrotic angle sum ≥190° based on sagittal and coronal MRI views or
    2. ARCO stage II associated with WOMAC® VA3.1 pain score ≥20 mm if necrotic angle sum <190° based on sagittal and coronal MRI views or
    3. ARCO stage II associated or not with pain if necrotic angle sum is ≥190° based on sagittal and coronal MRI views
    4. Associated with corticosteroid and/or with alcohol abuse and/or idiopathic
  • 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)

Exclusion Criteria:

Current symptoms and/or signs related to the disease under study

  • Exclusively diaphyseal or metaphyseal osteonecrotic lesion
  • Traumatic or hyperbaric osteonecrosis, or osteonecrosis associated with hemoglobinopathy or coagulopathy (e.g., thalassemia, sickle cell disease,…), or Gaucher's disease
  • Any other focal or diffuse bone marrow lesion
  • Osteoarthritis at the target hip defined as Kellgrens stage ≥2, as assessed by the Central Radiologist
  • Patients suffering from any medical conditions interfering with patient's pain evaluation of the hip under evaluation, such as knee arthritis.
  • Bone fracture or bone infection at hip under evaluation.
  • Patients who are candidates for any predictable joint replacement on the hip that is evaluated Current or previous diagnoses, signs and/or symptoms
  • 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.
  • Presence, or previous history, of risks factors for diseases caused by prions, and recipients of grafts of cornea, sclera, and dura mater
  • History of blood loss exceeding 450 ml (incl. donations) within 1 month of screening
  • Renal impairment defined by an estimated creatinine clearance value < 30 ml per min, calculated with the Cockcroft-Gault formula
  • Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper limit of normal
  • Poorly controlled diabetes mellitus, defined as HbA1C > 9%
  • Global sepsis
  • Allergy to gentamicin or porcine collagen 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
  • History of hypersensitivity to human biological material, including blood and blood derived products, documented clinically or by laboratory tests
  • 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)
  • History of bone marrow transplantation
  • Patients with a life expectancy less than 2 years, as judged by the Investigator Current or previous treatment
  • Patients having participated in another clinical trial within 3 months of screening
  • Patients previously treated with PREOB®
  • Patients treated by core decompression of the hip under evaluation within 6 months of screening
  • 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
  • Illicit drug or alcohol abuse interfering with patient's ability to understand and comply with study requirements, as judged by the Investigator

Safety aspects concerning female patients of childbearing potential

  • Pregnancy
  • Breast-feeding
  • Women with childbearing potential not willing or able to use reliable contraceptive method for at least 6 weeks prior to screening and during the whole study period. Reliable contraceptive methods include orally administered hormonal contraceptives, surgical intervention (e.g., tubal ligation), and intrauterine device (IUD).

Other exclusion criteria:

  • Body Mass Index (BMI) ≥ 35 kg/m2
  • Patients unable to undergo MRI, e.g. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves
  • Patients unable to undergo general anaesthesia or surgical intervention
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529008


Contacts
Contact: Thomas Lienard, MBA preob.on3@bonetherapeutics.com
Contact: Guy Heynen, MD guy.heynen@bonetherapeutics.com

Locations
Belgium
Investigative site BE06 Recruiting
Aalst, Belgium
Investigative site BE01 Recruiting
Anderlecht, Belgium
Investigative site BE09 Recruiting
Antwerpen, Belgium
Investigative site BE04 Recruiting
Brugge, Belgium
Investigative site BE02 Recruiting
Brussels, Belgium
Investigative site BE 05 Terminated
Dendermonde, Belgium
Investigative site BE13 Terminated
Edegem, Belgium
Investigative site BE14 Recruiting
Genk, Belgium
Investigative site BE10 Recruiting
Gent, Belgium
Investigative site BE15 Recruiting
Gent, Belgium
Investigative site BE16 Recruiting
Hasselt, Belgium
Investigative site BE11 Recruiting
Kortrijk, Belgium
Investigative site BE08 Recruiting
Liège, Belgium
Investigative site BE04 Recruiting
Oostende, Belgium
Investigative site BE07 Recruiting
Roeselare, Belgium
Investigative site BE03 Recruiting
Sint-Niklaas, Belgium
Investigative site BE12 Recruiting
Yvoir, Belgium
France
Investigative site FR04 Recruiting
Amiens, France
Investigative site FR12 Not yet recruiting
Brest, France
Investigative site- FR09 Not yet recruiting
Corbeil-Essonnes, France
Investigative site FR Not yet recruiting
Créteil, France
Investigative site FR Not yet recruiting
Lille, France
Investigative site FR02 Recruiting
Nancy, France
Investigative site FR01 Recruiting
Saint-Etienne, France
Germany
Investigative site DE05 Recruiting
Dresden, Germany
Investigative site DE07 Recruiting
Eisenberg, Germany
Investigative site DE06 Recruiting
Greifswald, Germany
Investigative site DE01 Recruiting
Hannover, Germany
Investigative site DE02 Recruiting
Köln, Germany
Investigative site DE04 Recruiting
Würzburg, Germany
Netherlands
Investigative site NL01 Recruiting
Rotterdam, Netherlands
United Kingdom
Investigative site UK07 Recruiting
Birmingham, United Kingdom
Investigative site UK01 Recruiting
Cambridge, United Kingdom
Investigative site UK06 Recruiting
London, United Kingdom
Investigative site UK03 Not yet recruiting
Oswestry, United Kingdom
Investigative site UK05 Recruiting
Southampton, United Kingdom
Investigative site UK09 Not yet recruiting
Wigan, United Kingdom
Sponsors and Collaborators
Bone Therapeutics S.A
  More Information

Responsible Party: Bone Therapeutics S.A
ClinicalTrials.gov Identifier: NCT01529008     History of Changes
Other Study ID Numbers: PREOB-ON3
First Submitted: February 2, 2012
First Posted: February 8, 2012
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Bone Therapeutics S.A:
Osteonecrosis
Femoral Head
Hip
Orthopedics
Bone
Musculoskeletal Disorders

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes