AK1320 Microspheres for Spinal Stenosis

(ENHANCE Trial)

No longer recruiting at 6 trial locations

Overseen By AK1320-101 Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Asahi Kasei Pharma Corporation

Disqualifiers: Prior lumbar surgery, Interbody fusion, Scoliosis, BMI > 40, Spinal instability, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by cohort

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AK1320 MS (microspheres) to determine its safety and effectiveness for individuals with spinal stenosis, a condition that narrows the spinal canal, often causing pain and movement difficulties. The trial compares AK1320 MS to the standard bone graft method used in spine surgeries. It targets individuals with spinal stenosis who experience symptoms like leg pain or difficulty walking. Participants should not have undergone previous spine surgeries and should require fusion at only one spinal level. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AK1320 MS is being tested in people for the first time to assess its safety. As this is the initial study involving humans, limited information exists about its tolerability or potential side effects. At this early stage, researchers focus primarily on ensuring its safety for humans, closely monitoring participants' responses to the treatment.

Early-stage trials like this one aim to determine a treatment's safety before evaluating its effectiveness. If any serious safety concerns arise with AK1320 MS, the study will address them before proceeding to further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spinal stenosis?

Unlike the standard treatments for spinal stenosis, which often involve medications, physical therapy, or traditional surgical approaches, AK1320 MS introduces a novel approach by utilizing microspheres combined with local autologous bone and posterior fixation. This treatment is unique because it leverages microspheres to potentially enhance bone healing and stability in the spine. Researchers are excited about AK1320 MS because it might offer a more targeted and efficient way to improve spinal support and reduce symptoms, potentially leading to quicker recovery times and better outcomes for patients with spinal stenosis.

What evidence suggests that AK1320 MS might be an effective treatment for spinal stenosis?

Research shows that AK1320 Microspheres (MS), one of the treatments tested in this trial, are being evaluated for their effectiveness in people with spinal stenosis. Early studies suggest that AK1320 MS might aid recovery after surgery for conditions like degenerative spondylolisthesis, where the spine's bones slip out of place. Initial results indicate that AK1320 MS could provide better pain relief and improve movement compared to pre-treatment levels. Although current information is limited, this treatment aims to enhance surgical outcomes by stabilizing the spine more effectively. Further research will clarify its potential benefits for people with spinal stenosis. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-80 with degenerative spondylolisthesis (Grade 1 or 2) and spinal stenosis causing moderate to severe disability. Participants must be undergoing specific spine fusion surgery using their own bone. Excluded are those with significant spinal instability, a BMI over 40, scoliosis requiring multi-level fusion, recent back surgeries, or involved in workers' comp claims.

Inclusion Criteria

I am between 22 and 80 years old.

My back pain significantly limits my daily activities.

I am using my own bone for the procedure.

Exclusion Criteria

You have a body mass index (BMI) greater than 40, which means you have severe obesity.

Active or recent (within the past two (2) years) worker's compensation litigation.

I need surgery to join two or more bones in my lower back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo decompression and single level instrumented posterolateral lumbar autograft fusion surgery with AK1320 MS or control treatment

Varies by cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurological status and successful fusion evaluation

24 months

What Are the Treatments Tested in This Trial?

Interventions

• AK1320 MS
• Control

Trial Overview The study tests AK1320 MS microspheres in patients having decompression and single-level spine fusion surgery for spondylolisthesis with spinal stenosis. It aims to assess the safety and effectiveness of this treatment compared to a control group not receiving the microspheres.

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 Intervention

Local Autologous Bone + Posterior Fixation

Group II: AK1320 MS Experimental Treatment 1 Intervention

AK1320 MS + Local Autologous Bone + Posterior Fixation

Who Is Running the Clinical Trial?

Asahi Kasei Pharma Corporation

Lead Sponsor

Trials

16

Recruited

2,800+

Emergent Clinical Consulting, LLC

Industry Sponsor

Trials

6

Recruited

2,900+

Citations

1. app.trialscreen.org app.trialscreen.org/trials/phase-1-degenerative-spondylolisthesis-first-human-ak1320-encapsulated-trial-nct04483297

First-In-Human Study of AK1320 Encapsulated ... The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal ...

2. go.drugbank.com go.drugbank.com/conditions/DBCOND0091978

Stenosis, Spinal (DBCOND0091978) Outcome of Surgery for Lumbar Spinal Stenosis - a Comparison of Data From Three National Quality Registries ... First-In-Human Study of AK1320 Encapsulated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319572/

Long-Term Safety and Efficacy of Minimally Invasive Lumbar ... All efficacy outcomes achieved clinically meaningful and statistically significant improvement from baseline to all follow-up intervals through 2 years. There ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11951193/

Three-year results of the MOTION randomized controlled trial ... All outcomes for this group were significantly improved over baseline (p-values ranging from <0.0001 to 0.0001). At 3-year, ODI, NPRS back and ...

5. researchgate.net researchgate.net/publication/235749589_Long-term_Results_of_Percutaneous_Lumbar_Decompression_for_LSS_Two-Year_Outcomes

Long-term Results of Percutaneous Lumbar ... ... In this prospective study, MILD patients experienced significant improvement in mobility and reduction of pain at 12-week, 6-month, and one-year follow-up.

6. mentalhealth.networkofcare.org mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials?keyword=%22Degenerative%20Spondylolisthesis%22

Lake Clinical Trials - Behavioral Health - Network of Care The safety and efficacy of AK1320 MS will be ... Safety and performance data obtained ... Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis.

7. centerwatch.com centerwatch.com/clinical-trials/listings/condition/469/ankylosing-spondylitis?activelyRecruiting=false&page=29

Ankylosing Spondylitis Clinical Research Trials This will be a first in human Phase I, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, PK of AK1320 MS. The study will ...

8. malacards.org malacards.org/card/spinal_stenosis

Spinal Stenosis Integrated disease information for Spinal Stenosis including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 data ...