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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
ALLOB® cells with ceramic scaffold
Sponsored by
Bone Therapeutics S.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Spinal Fusion, Lumbar Interbody Fusion, Degenerative Disc Disease, Cell Therapy, Bone Graft

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Investigating site BE01
  • Investigating site BE03
  • Investigating site BE05
  • Investigating site BE02
  • Investigating site BE04
  • Investigating site BE08
  • Investigating site BE07
  • Investigating site BE06

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALLOB® cells with ceramic scaffold

Arm Description

ALLOB® cells with ceramic scaffold Implantation

Outcomes

Primary Outcome Measures

Lumbar fusion progression as assessed by CT scan
Functional Disability using Oswestry Disability Index
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

Secondary Outcome Measures

Pain using a Visual Analogue Scale
Global Disease Evaluation using a Visual Analogue Scale
Functional Disability using Oswestry Disability Index
Lumbar fusion progression as assessed by CT scan
Percentage of patients having a rescue surgery
Potential occurrence of any AE or SAE related to the product or to the procedure

Full Information

First Posted
July 30, 2014
Last Updated
January 28, 2021
Sponsor
Bone Therapeutics S.A
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1. Study Identification

Unique Protocol Identification Number
NCT02205138
Brief Title
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Official Title
A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Lumbar Spinal Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bone Therapeutics S.A

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Spinal Fusion, Lumbar Interbody Fusion, Degenerative Disc Disease, Cell Therapy, Bone Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALLOB® cells with ceramic scaffold
Arm Type
Experimental
Arm Description
ALLOB® cells with ceramic scaffold Implantation
Intervention Type
Drug
Intervention Name(s)
ALLOB® cells with ceramic scaffold
Intervention Description
Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
Primary Outcome Measure Information:
Title
Lumbar fusion progression as assessed by CT scan
Time Frame
12 months
Title
Functional Disability using Oswestry Disability Index
Time Frame
12 months
Title
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain using a Visual Analogue Scale
Time Frame
12 months
Title
Global Disease Evaluation using a Visual Analogue Scale
Time Frame
12 months
Title
Functional Disability using Oswestry Disability Index
Time Frame
12 months
Title
Lumbar fusion progression as assessed by CT scan
Time Frame
12 months
Title
Percentage of patients having a rescue surgery
Time Frame
12 months
Title
Potential occurrence of any AE or SAE related to the product or to the procedure
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Investigating site BE01
City
Brussels
Country
Belgium
Facility Name
Investigating site BE03
City
Brussels
Country
Belgium
Facility Name
Investigating site BE05
City
Brussels
Country
Belgium
Facility Name
Investigating site BE02
City
Charleroi
Country
Belgium
Facility Name
Investigating site BE04
City
Genk
Country
Belgium
Facility Name
Investigating site BE08
City
Kortrijk
Country
Belgium
Facility Name
Investigating site BE07
City
Liège
Country
Belgium
Facility Name
Investigating site BE06
City
Mons
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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