Degenerative Disc Disease Clinical Trial
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
Verified date | January 2021 |
Source | Bone Therapeutics S.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 25, 2021 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
Bone Therapeutics S.A |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lumbar fusion progression as assessed by CT scan | 12 months | ||
Primary | Functional Disability using Oswestry Disability Index | 12 months | ||
Primary | 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 | Pain using a Visual Analogue Scale | 12 months | ||
Secondary | Global Disease Evaluation using a Visual Analogue Scale | 12 months | ||
Secondary | Functional Disability using Oswestry Disability Index | 12 months | ||
Secondary | Lumbar fusion progression as assessed by CT scan | 12 months | ||
Secondary | Percentage of patients having a rescue surgery | 12 months | ||
Secondary | Potential occurrence of any AE or SAE related to the product or to the procedure | 36 months |
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