A Phase 2 interventional study of ALLOB® cells with ceramic scaffold in Degenerative Disc Disease, sponsored by Bone Therapeutics S.A. Completed at 8 sites in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by Bone Therapeutics S.A · Phase 2, Interventional, and Treatment
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Bone Therapeutics S.A is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Lumbar fusion progression as assessed by CT scan
Time frame: 12 months
Functional Disability using Oswestry Disability Index
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: 12 months
Pain using a Visual Analogue Scale
Time frame: 12 months
Global Disease Evaluation 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
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
Time frame: 36 months
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
Bone Therapeutics S.A