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Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328287
Recruitment Status : Terminated
First Posted : December 31, 2014
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bone Therapeutics S.A

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.


Condition or disease Intervention/treatment Phase
Failed Lumbar Fusion Drug: ALLOB® Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 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 Rescue Interbody Fusion
Actual Study Start Date : September 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: ALLOB® Implantation Drug: ALLOB®
Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.




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, using patient open non-directive questionnaire, physical examination and laboratory measurements [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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
  • Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1

Exclusion Criteria:

  • 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

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): NCT02328287


Locations
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Belgium
Investigating site BE01
Anderlecht, Belgium
Investigating site BE02
Charleroi, Belgium
Investigating site BE04
Genk, Belgium
Sponsors and Collaborators
Bone Therapeutics S.A
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Responsible Party: Bone Therapeutics S.A
ClinicalTrials.gov Identifier: NCT02328287    
Other Study ID Numbers: ALLOB-RIF1
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by Bone Therapeutics S.A:
Spinal Fusion
Revision Surgery
Pseudarthrosis
Cell Therapy
Bone Graft