Low Back PainNCT02932020
AlloGen-LI Treatment of Spinal Stenosis
A study testing AlloGen-LI, depomedrol and MRI in people with Low Back Pain, run by University of Southern California at 1 site in United States.
Trial summary
In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- AlloGen-LI, depomedrol and MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2017
- Phase
- Interventional
- 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
- Low back pain of > 4-5 weeks but < 6-7 months
- Evidence of at least mild lumbar stenosis /disc herniation on MRI
- Failure of conservative therapy to include physical therapy and pharmacotherapy
- Patient is at least 18 years of age
- Patient is willing to be blinded to treatment until after the 12 week post injection visit
- Patient is willing and able to review and sign the study informed consent form
Who cannot join
- 1. No evidence of lumbar stenosis or disc herniation on MRI 2. Patient has had prior lumbar surgery at any level 3. Patient has received epidural steroid injection in the past 6 months 4. Patient currently receives systemic steroids for another medical condition 5. Patient is pregnant 6. Patient has systemic infection at the proposed injection site 7. Patient has a systemic malignancy 8. Current therapy with any immunosuppressive medication 9. History of solid organ or hematologic transplantation 10 History of autoimmune disorder 11. Patient has known allergy to lidocaine, marcaine or steroid 12. Devices and conditions that are contraindications for MRI examination (routinely screened before all MRI examinations).
- 13. Patient is on anticoagulant medications (other than ASA). 14. Patient has eGFR of <40 15. Patient has known chronic kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of USC
Los Angeles, California, 90033
About this study
Official title: Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2 signal related to that reflect inflammation and degeneration.
Read the detailed description
AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of osteorarthritis and degenerative disc disease. Anti-inflammatory components include inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues, including amniotic fluid, amniotic membrane and chorion are regulated as human cell and tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft materials for human injection. AlloGen-LI is derived from placental tissues obtained from carefully screened healthy mothers at the time of scheduled cesarean section. The mothers have agreed to donate the tissues, which would otherwise be discarded. The experimental treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural space under CT guidance, in an identical manner to traditional epidural steroid /marcaine injections.
- Conditions
- Low Back Pain
- Being tested
- AlloGen-LI, depomedrol, MRI, 0.5% marcaine
- Keywords
- disc herniation, spinal stenosis
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloGen-LIDrug
Also called Interlaminar Epidural Injection-AlloGen-LI
interlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI
depomedrolDrug
Also called Interlaminar Epidural Injection-Standard
interlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml)
MRIDevice
contrast enhanced MRI of the lumbar spine performed at Visit 1 and Visit 6 weeks (+7 days)
0.5% marcaineDrug
epidural injection of 2mL 0.5% marcaine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Randomized 10 subjects
Visit 1:
1st contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine interlaminar epidural injection of (a) 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI
Visit: 6 weeks (+7days): 2nd contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine Receives: Drug: AlloGen-LI; Device: MRI; Drug: 0.5% marcaine |
| Group B | Other | Randomized 10 subjects
Visit 1:
1st contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine interlaminar epidural injection 2mL 0.5% marcaine and 1mL and 1mL steroid (depomedrol 80mg/ml).
Visit 6 weeks (+7days): 2nd contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine Receives: Drug: depomedrol; Device: MRI; Drug: 0.5% marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Cohen's d25 will be calculated at each permutation iteration. The empirical distribution of Cohen's d will then be calculated with a 95% confidence interval (CI).
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- VIVEX Biologics, Inc.
- Responsible party
- Principal investigator, Wende Gibbs, University of Southern California
- Investigators
- Wende Gibbs, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932020
- Sponsor's protocol ID
- HS-15-00576
- Status last verified
- May 2018
- First submitted
- 4 Oct 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
- ClinicalTrials.gov ID
- NCT02932020
- Acronym / sponsor ID
- HS-15-00576
- Conditions
- Low Back Pain
- Keywords
- disc herniation, spinal stenosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- VIVEX Biologics, Inc.
- Study start
- Oct 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 13 Oct 2016 (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.
In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2 signal related to that reflect inflammation and degeneration.
Detailed description
AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of osteorarthritis and degenerative disc disease. Anti-inflammatory components include inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues, including amniotic fluid, amniotic membrane and chorion are regulated as human cell and tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft materials for human injection. AlloGen-LI is derived from placental tissues obtained from carefully screened healthy mothers at the time of scheduled cesarean section. The mothers have agreed to donate the tissues, which would otherwise be discarded. The experimental treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural space under CT guidance, in an identical manner to traditional epidural steroid /marcaine injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: AlloGen-LI, Device: MRI, Drug: 0.5% marcaineRandomized 10 subjects Visit 1: 1st contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine interlaminar epidural injection of (a) 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI Visit: 6 weeks (+7days): 2nd contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine |
| Group B | Other | Drug: depomedrol, Device: MRI, Drug: 0.5% marcaineRandomized 10 subjects Visit 1: 1st contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine interlaminar epidural injection 2mL 0.5% marcaine and 1mL and 1mL steroid (depomedrol 80mg/ml). Visit 6 weeks (+7days): 2nd contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Low back pain of > 4-5 weeks but < 6-7 months
- Evidence of at least mild lumbar stenosis /disc herniation on MRI
- Failure of conservative therapy to include physical therapy and pharmacotherapy
- Patient is at least 18 years of age
- Patient is willing to be blinded to treatment until after the 12 week post injection visit
Key exclusion criteria (2 listed)
- 1. No evidence of lumbar stenosis or disc herniation on MRI 2. Patient has had prior lumbar surgery at any level 3. Patient has received epidural steroid injection in the past 6 months 4. Patient currently receives systemic steroids for another medical condition 5. Patient is pregnant 6. Patient has systemic infection at the proposed injection site 7. Patient has a systemic malignancy 8. Current therapy with any immunosuppressive medication 9. History of solid organ or hematologic transplantation 10 History of autoimmune disorder 11. Patient has known allergy to lidocaine, marcaine or steroid 12. Devices and conditions that are contraindications for MRI examination (routinely screened before all MRI examinations).
- 13. Patient is on anticoagulant medications (other than ASA). 14. Patient has eGFR of <40 15. Patient has known chronic kidney disease
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 |
|---|---|---|
| AlloGen-LIAlso: Interlaminar Epidural Injection-AlloGen-LIinterlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI | Drug | Group A |
| depomedrolAlso: Interlaminar Epidural Injection-Standardinterlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml) | Drug | Group B |
| MRIcontrast enhanced MRI of the lumbar spine performed at Visit 1 and Visit 6 weeks (+7 days) | Device | Group A, Group B |
| 0.5% marcaineepidural injection of 2mL 0.5% marcaine | Drug | Group A, Group B |
Primary outcome
Pain Reduction
Time frame: 6-12 weeks
Cohen's d25 will be calculated at each permutation iteration. The empirical distribution of Cohen's d will then be calculated with a 95% confidence interval (CI).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Wende Gibbs, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlloGen-LI, depomedrol and MRI in people with Low Back Pain, run by University of Southern California at 1 site in United States.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain Reduction (time frame: 6-12 weeks). 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 May 2018.