Failed Lumbar FusionPhase 2NCT02328287
Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion
A Phase 2 study testing ALLOB® in people with Failed Lumbar Fusion, run by Bone Therapeutics S.A at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Lumbar Fusion
- What is being tested?
- ALLOB®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesBelgium
- Study dates
- Sep 2014to Apr 2020
- 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 years and older
- 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
- Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Investigating site BE01
Anderlecht
Investigating site BE02
Charleroi
Investigating site BE04
Genk
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 Rescue Interbody Fusion
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.
- Conditions
- Failed Lumbar Fusion
- Being tested
- ALLOB®
- Keywords
- Spinal Fusion, Revision Surgery, Pseudarthrosis, Cell Therapy, Bone Graft
- Medical subject headings
- Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLOB®Drug
Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| ALLOB® Implantation | Experimental | Not described Receives: Drug: ALLOB® |
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, using patient open non-directive questionnaire, physical examination and laboratory measurements
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 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2018
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Lumbar FusionStudies 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
- 6 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
- NCT02328287
- Sponsor's protocol ID
- ALLOB-RIF1
- Status last verified
- Jun 2020
- First submitted
- 23 Dec 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. 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 Rescue Interbody Fusion
- ClinicalTrials.gov ID
- NCT02328287
- Acronym / sponsor ID
- ALLOB-RIF1
- Conditions
- Failed Lumbar Fusion
- Keywords
- Spinal Fusion, Revision Surgery, Pseudarthrosis, Cell Therapy, Bone Graft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bone Therapeutics S.AIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 31 Dec 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLOB® Implantation | Experimental | Drug: ALLOB® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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
- Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1
Key exclusion criteria (5 listed)
- 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
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®Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia. | Drug | ALLOB® Implantation |
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, using patient open non-directive questionnaire, physical examination and laboratory measurements
Time frame: 36 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Related trials for Failed Lumbar Fusion
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
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.
3 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® in people with Failed Lumbar Fusion, run by Bone Therapeutics S.A at 3 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 2 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: stopped early, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early. Results are not available in the source record.
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 11 Jun 2020.