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 3

Completed

• Conditions: Nontraumatic osteonecrosis of the femoral head; Tissuedegeneration in femoral head; 10005959

• Registration Number: NL-OMON45063
• Lead Sponsor: Bone Therapeutics

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Results First Posted: 2020-06-26
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Men and women, aged 18 to 70 years old, diagnosed with:
- an ARCO stage I osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding the screening)
- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which can be either symptomatic or asymptomatic
- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles inferior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding)

Exclusion Criteria

ARCO stage III and IV osteonecrosis of the femoral head on the hip which is evaluated, and confirmed by conventional X-ray and and MRI of the hip.
Osteoarthritis on the hip. Bone fracture that might interfere with study evaluation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified