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

NCT02890537 | Completed Phase 2

• 1 other identifier: 2003/281
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Avascular Necrosis of Femur Head

Keywords

Osteonecrosis; Femoral Head; Hip; Orthopedics; Bone; Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (2)

• Percentage of responder subjects

  Response defined as the absence of progression to fractural stage (ARCO stage III or higher) \& a clinically significant pain improvement

  24 months

• 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

  60 months

Secondary Outcomes (7)

• Percentage of responder subjects

  3, 6, 12 and 36 months

• Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray

  3, 6, 12, 24 and 36 months

• Change from baseline in VAS pain score

  3, 6, 12, 18, 24, 36 and 48 months

• Change from baseline in WOMAC® score

  3, 6, 12, 18, 24, 36 and 48 months

• Change from baseline in Lequesne score

  3, 6, 12, 18, 24, 36 and 48 months

Study Arms (2)

Core decompression/PREOB® implantation

EXPERIMENTAL

Core decompression/autologous osteoblastic cells (PREOB®) implantation

Drug: Core decompression/PREOB® implantation

Core decompression/BMC implantation

ACTIVE COMPARATOR

Core decompression/bone marrow concentrate (BMC) implantation

Drug: Core decompression/BMC implantation

Interventions

Core decompression/PREOB® implantation DRUG

All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).

Core decompression/PREOB® implantation

Core decompression/BMC implantation DRUG

All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).

Core decompression/BMC implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead
• University of Liege: collaborator
• Bone Therapeutics S.A: collaborator

Study Sites (2)

Investigative site 01

Brussels, Belgium

Location

Investigative site 02

Liège, Belgium

Location

MeSH Terms

Conditions

Femur Head Necrosis; Osteonecrosis; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 7, 2016
• Study Start: October 1, 2003
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)