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

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ClinicalTrials.gov Identifier: NCT02205138
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Bone Therapeutics S.A

Study Description
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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.


Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Drug: ALLOB® cells with ceramic scaffold Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : February 2019
Actual Study Completion Date : January 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ALLOB® cells with ceramic scaffold
ALLOB® cells with ceramic scaffold Implantation
 Drug: ALLOB® cells with ceramic scaffold
Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia


Outcome Measures
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Primary Outcome Measures :
  1. Lumbar fusion progression as assessed by CT scan [ Time Frame: 12 months ]
  2. Functional Disability using Oswestry Disability Index [ Time Frame: 12 months ]
  3. 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 Measures :
  1. Pain using a Visual Analogue Scale [ Time Frame: 12 months ]
  2. Global Disease Evaluation using a Visual Analogue Scale [ Time Frame: 12 months ]
  3. Functional Disability using Oswestry Disability Index [ Time Frame: 12 months ]
  4. Lumbar fusion progression as assessed by CT scan [ Time Frame: 12 months ]
  5. Percentage of patients having a rescue surgery [ Time Frame: 12 months ]
  6. Potential occurrence of any AE or SAE related to the product or to the procedure [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205138


Locations
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Belgium
Investigating site BE01
Brussels, Belgium
Investigating site BE03
Brussels, Belgium
Investigating site BE05
Brussels, Belgium
Investigating site BE02
Charleroi, Belgium
Investigating site BE04
Genk, Belgium
Investigating site BE08
Kortrijk, Belgium
Investigating site BE07
Liège, Belgium
Investigating site BE06
Mons, Belgium
Sponsors and Collaborators
Bone Therapeutics S.A
More Information
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Responsible Party: Bone Therapeutics S.A
ClinicalTrials.gov Identifier: NCT02205138    
Other Study ID Numbers: ALLOB-IF1
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Keywords provided by Bone Therapeutics S.A:
Spinal Fusion
Lumbar Interbody Fusion
Degenerative Disc Disease
Cell Therapy
Bone Graft
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases