Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion

NCT02205138 | Completed Phase 2

• 1 other identifier: ALLOB-IF1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 8

Brief Summary

Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon. The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.

Conditions

Degenerative Disc Disease

Keywords

Spinal Fusion; Lumbar Interbody Fusion; Degenerative Disc Disease; 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® cells with ceramic scaffold

EXPERIMENTAL

ALLOB® cells with ceramic scaffold Implantation

Drug: ALLOB® cells with ceramic scaffold

Interventions

ALLOB® cells with ceramic scaffold DRUG

Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia

ALLOB® cells with ceramic scaffold

Eligibility Criteria

• Age: 18 Years - 75 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
• Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)
• Unresponsive to non-operative treatment for at least 6 months

You may not qualify if:

• Lumbar disc disease requiring treatment at more than one level
• Previous failed fusion at the involved lumbar level
• Local active or latent infection at the involved lumbar level
• 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 (8)

Investigating site BE01

Brussels, Belgium

Location

Investigating site BE03

Brussels, Belgium

Location

Investigating site BE05

Brussels, Belgium

Location

Investigating site BE02

Charleroi, Belgium

Location

Investigating site BE04

Genk, Belgium

Location

Investigating site BE08

Kortrijk, Belgium

Location

Investigating site BE07

Liège, Belgium

Location

Investigating site BE06

Mons, Belgium

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

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: July 30, 2014
• First Posted: July 31, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: January 25, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

BE (8)