What side effects are associated with this type of intervention?

Common treatments for spinal stenosis, particularly surgical interventions like decompression and spinal fusion, can have several side effects. These may include infection, bleeding, blood clots, nerve damage, and issues related to anesthesia. Post-surgical complications can also involve pain at the graft site, hardware failure, and adjacent segment disease, where nearby spinal segments degenerate faster. Therapeutic agents used to enhance surgical outcomes, such as AK1320 MS, may introduce additional risks like inflammatory reactions, allergic responses, or other site-specific complications. It is essential to discuss these potential side effects with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for spinal stenosis, particularly those that aim to enhance surgical outcomes in spinal fusion surgery. These include bone graft substitutes and growth factors like bone morphogenetic proteins (e.g., BMP-2), which promote bone healing and fusion. Additionally, devices such as interbody cages and spinal implants have been approved to provide structural support and stability during the fusion process. While AK1320 MS is a novel therapeutic agent under investigation, it aligns with the broader category of treatments designed to improve the efficacy and outcomes of spinal fusion surgeries.

What other types of research exist?

Promising novel alternatives to AK1320 MS for spinal stenosis patients include the use of bosutinib, an oral tyrosine kinase inhibitor, which has shown efficacy in reducing kidney growth in ADPKD and may have potential applications in spinal conditions. Additionally, advancements in surgical techniques such as the use of cortical ring allografts combined with spinal locking plates, as demonstrated in canine models, may offer improved outcomes. Further research and clinical trials are necessary to confirm their efficacy in human spinal stenosis patients.

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AK1320 Microspheres for Spinal Stenosis (ENHANCE Trial)

Phase 1

Waitlist Available

Research Sponsored by Asahi Kasei Pharma Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female over 22 years of age and less than 81 years of age.

Moderate or higher disability as assessed by Oswestry Disability Index.

Must not have

Requires spinal fusion at more than one lumbar level.

Radiographically confirmed significant spinal instability.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing AK1320 MS, a new treatment for serious back problems, in patients having back surgery. They are checking different doses to see if it is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of AK1320 MS aren't detailed here, typical risks may include inflammation at the injection site, pain, infection risk from surgery, possible allergic reactions to materials used in microspheres, or complications related to spine surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 80 years old.

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My back pain significantly limits my daily activities.

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I am using my own bone for the procedure.

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My condition affects my lower spine from L1 to S1.

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My spine condition is classified as mild to moderate.

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I experience leg pain from nerve issues, with or without back pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My spine is significantly unstable, confirmed by imaging tests.

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I have degenerative scoliosis.

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I am currently having a spine fusion surgery.

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I have had surgery before to relieve pressure on my spinal cord or to fuse spine bones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Summary of Neurological Status

Secondary study objectives

Successful Fusion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ControlExperimental Treatment1 Intervention

Local Autologous Bone + Posterior Fixation

Group II: AK1320 MSExperimental Treatment1 Intervention

AK1320 MS + Local Autologous Bone + Posterior Fixation

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for spinal stenosis include decompression surgery, spinal fusion, and various pharmacologic agents. Decompression surgery aims to relieve pressure on the spinal cord or nerves by removing parts of the bone or tissue causing the compression. Spinal fusion involves joining two or more vertebrae to stabilize the spine, often using bone grafts or synthetic materials. Pharmacologic agents, such as anti-inflammatory drugs, help reduce inflammation and pain. The potential therapeutic agent AK1320 MS, being studied for use in spinal fusion surgery, likely aims to enhance the surgical outcomes by promoting bone growth and stability, thereby improving the overall success rate of the fusion procedure. These treatments are crucial for spinal stenosis patients as they address the underlying causes of pain and mobility issues, leading to improved quality of life.