First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asahi Kasei Pharma Corporation
• Collaborators: Emergent Clinical Consulting; Emergent Clinical Consulting, LLC

Criteria

Inclusion Criteria:

1. Involved level L1 to S1

2. Use of local autologous bone only.

3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.

4. Moderate or higher disability as assessed by Oswestry Disability Index.

5. Neurogenic claudication and/or radiculopathy with or without back pain.

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

Exclusion Criteria:

1. Prior lumbar decompression or spine fusion attempt (any level).

2. Undergoing concurrent interbody fusion.

3. Requires spinal fusion at more than one lumbar level.

4. Degenerative scoliosis.

5. BMI > 40.

6. Radiographically confirmed significant spinal instability.

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