Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02328287
• Date of registration: 23/12/2014
• Prospective Registration: No
• Primary sponsor: Bone Therapeutics S.A
• Public title: Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion
• Scientific 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
• Date of first enrolment: September 2014
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02328287
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Failed Lumbar Fusion

Intervention(s)

Drug: ALLOB®

Primary Outcome(s)

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]

Functional Disability using Oswestry Disability Index [Time Frame: 12 months]

Lumbar fusion progression as assessed by CT scan [Time Frame: 12 months]

Secondary Outcome(s)

Global Disease Evaluation using a Visual Analogue Scale [Time Frame: 12 months]

Percentage of patients having a rescue surgery [Time Frame: 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 [Time Frame: 36 months]

Pain using a Visual Analogue Scale [Time Frame: 12 months]

Functional Disability using Oswestry Disability Index [Time Frame: 12 months]

Lumbar fusion progression as assessed by CT scan [Time Frame: 12 months]

Secondary ID(s)

ALLOB-RIF1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors