AK1320 Microspheres for Spinal Stenosis

(ENHANCE Trial)

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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment AK1320 MS for spinal stenosis?

The research suggests that epidural steroid injections, which are similar to the treatment being studied, may offer little-to-no short-term benefit for spinal stenosis compared to lidocaine alone, indicating that the effectiveness of such treatments can vary. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Who should have surgery for spinal stenosis? Treatment effect predictors in SPORT. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Lumbar Spinal Stenosis Severity by CT or MRI Does Not Predict Response to Epidural Corticosteroid versus Lidocaine Injections. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Lumbar spinal stenosis. Clinical and radiologic features. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Changes in objectively measured physical activity (performance) after epidural steroid injection for lumbar spinal stenosis. [2022]