Clinical trial NCT02890537: Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
Official title: Treatment of Osteonecrosis of the Femoral Head by Implantation of Preosteoblastic Cells: a Randomized, Controlled, Single Blind Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Avascular Necrosis of Femur Head
Keywords: Osteonecrosis
Femoral Head
Hip
Orthopedics
Bone
Musculoskeletal Disorders
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: University of Liege
name: Bone Therapeutics S.A
First posted: 2016-09-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. The primary goal of this study was to investigate the safety and efficacy of the implantation of the investigational product PREOB® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a follow-up period of up to 5 years.


Eligibility criteria: Inclusion Criteria:

* ARCO stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray and magnetic resonance imaging (MRI) of the hip
* Aged 18 or higher
* Ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements

Exclusion Criteria:

* Evidence of malignant disorder in the past five years
* Positive serology for hepatitis B, hepatitis C, HIV
* Patient unable to undergo a MRI

Primary outcomes:
measure: Percentage of responder subjects
timeFrame: 24 months
measure: Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
timeFrame: 60 months
Secondary outcomes:
measure: Percentage of responder subjects
timeFrame: 3, 6, 12 and 36 months
measure: Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray
timeFrame: 3, 6, 12, 24 and 36 months
measure: Change from baseline in VAS pain score
timeFrame: 3, 6, 12, 18, 24, 36 and 48 months
measure: Change from baseline in WOMAC® score
timeFrame: 3, 6, 12, 18, 24, 36 and 48 months
measure: Change from baseline in Lequesne score
timeFrame: 3, 6, 12, 18, 24, 36 and 48 months
measure: Proportion of subjects undergoing a total hip arthroplasty
timeFrame: 6, 12, 24 and 36 months
measure: Time to hip fracture
timeFrame: 36 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Investigative site 01
city: Liege
country: Belgium
facility: Investigative site 02
Study officials:
References: