Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

NCT02328287 | Terminated Phase 2

• 1 other identifier: ALLOB-RIF1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results. The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.

Conditions

Failed Lumbar Fusion

Keywords

Spinal Fusion; Revision Surgery; Pseudarthrosis; Cell Therapy; Bone Graft

Outcome Measures

Primary Outcomes (3)

• Lumbar fusion progression as assessed by CT scan

  12 months

• Functional Disability using Oswestry Disability Index

  12 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

  12 months

Secondary Outcomes (6)

• Pain using a Visual Analogue Scale

  12 months

• Global Disease Evaluation using a Visual Analogue Scale

  12 months

• Functional Disability using Oswestry Disability Index

  12 months

• Lumbar fusion progression as assessed by CT scan

  12 months

• Percentage of patients having a rescue surgery

  12 months

Study Arms (1)

ALLOB® Implantation

EXPERIMENTAL

Drug: ALLOB®

Interventions

ALLOB® DRUG

Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.

ALLOB® Implantation

Eligibility Criteria

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

You may qualify if:

• Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
• Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1

You may not qualify if:

• More than two failed interbody fusions at the involved lumbar level(s)
• Instrumentation failure requiring revision surgery
• Local active or latent infection at the involved lumbar level(s)
• Positive serology for hepatitis B, hepatitis C, HIV
• Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator

Sponsors & Collaborators

• Bone Therapeutics S.A: lead

Study Sites (3)

Investigating site BE01

Anderlecht, Belgium

Location

Investigating site BE02

Charleroi, Belgium

Location

Investigating site BE04

Genk, Belgium

Location

MeSH Terms

Conditions

Pseudarthrosis

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 31, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

BE (3)