Degenerative Disc DiseasePhase 2NCT02205138
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
A Phase 2 study testing ALLOB® cells with ceramic scaffold in people with Degenerative Disc Disease, run by Bone Therapeutics S.A at 8 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- ALLOB® cells with ceramic scaffold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 8 sitesBelgium
- Study dates
- Oct 2014to 25 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
Investigating site BE01
Brussels
Investigating site BE03
Brussels
Investigating site BE05
Brussels
Investigating site BE02
Charleroi
Investigating site BE04
Genk
Investigating site BE08
Kortrijk
Investigating site BE07
Liège
Investigating site BE06
Mons
About this study
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
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.
- Conditions
- Degenerative Disc Disease
- Being tested
- ALLOB® cells with ceramic scaffold
- Keywords
- Spinal Fusion, Lumbar Interbody Fusion, Degenerative Disc Disease, Cell Therapy, Bone Graft
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLOB® cells with ceramic scaffoldDrug
Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| ALLOB® cells with ceramic scaffold | Experimental | ALLOB® cells with ceramic scaffold Implantation Receives: Drug: ALLOB® cells with ceramic scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar fusion progression as assessed by CT scan
Measured: 12 months
Functional Disability using Oswestry Disability Index
Measured: 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
Measured: 12 months
Secondary outcomes (6)
Pain using a Visual Analogue Scale
Measured: 12 months
Global Disease Evaluation using a Visual Analogue Scale
Measured: 12 months
Functional Disability using Oswestry Disability Index
Measured: 12 months
Lumbar fusion progression as assessed by CT scan
Measured: 12 months
Percentage of patients having a rescue surgery
Measured: 12 months
Potential occurrence of any AE or SAE related to the product or to the procedure
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2019
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bone Therapeutics S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205138
- Sponsor's protocol ID
- ALLOB-IF1
- Status last verified
- Jan 2021
- First submitted
- 30 Jul 2014
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02205138
- Acronym / sponsor ID
- ALLOB-IF1
- Conditions
- Degenerative Disc Disease
- Keywords
- Spinal Fusion, Lumbar Interbody Fusion, Degenerative Disc Disease, Cell Therapy, Bone Graft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bone Therapeutics S.AIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLOB® cells with ceramic scaffold | Experimental | Drug: ALLOB® cells with ceramic scaffoldALLOB® cells with ceramic scaffold Implantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLOB® cells with ceramic scaffoldEach patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia | Drug | ALLOB® cells with ceramic scaffold |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLOB® cells with ceramic scaffold in people with Degenerative Disc Disease, run by Bone Therapeutics S.A at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar fusion progression as assessed by CT scan (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.