Trial | NCT04483297  Report issue

Title

First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    AK1320 MS ...

  • Study Participants

    40
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.
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 enroll up to 4 dose escalating cohorts with each cohort having 2 treatment groups, the AK1320 MS group (n=7) and the Control group (n=3).
Study Started
Nov 18
2020
Primary Completion
Dec 31
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Feb 02
2023

Drug AK1320 MS

AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.

Other Control

Local Autologous Bone + Posterior Fixation

AK1320 MS Experimental

AK1320 MS + Local Autologous Bone + Posterior Fixation

Control Other

Local Autologous Bone + Posterior Fixation

Criteria 

Inclusion Criteria:

Involved level L1 to S1
Use of local autologous bone only.
Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.
Moderate or higher disability as assessed by Oswestry Disability Index.
Neurogenic claudication and/or radiculopathy with or without back pain.
Male or female over 22 years of age and less than 81 years of age.

Exclusion Criteria:

Prior lumbar decompression or spine fusion attempt (any level).
Undergoing concurrent interbody fusion.
Requires spinal fusion at more than one lumbar level.
Degenerative scoliosis.
BMI > 40.
Radiographically confirmed significant spinal instability.
Active or recent (within the past two (2) years) worker's compensation litigation.
No Results Posted