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

Phase 1

• Conditions: Osteonecrosis of the Femoral Head; MedDRA version: 20.0 Level: PT Classification code 10031264 Term: Osteonecrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2009-012929-11-DE
• Lead Sponsor: Bone Therapeutics S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-22
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 118

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
or
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
or
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) yes
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 interferin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified