NCT04378543

Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion

A Phase 1b/2a Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Ankasa Regenerative Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Ankasa Regenerative Therapeutics, Inc. (Ankasa) is developing ART352-L, a liposomal formulation of recombinant human Wnt3A protein, that is applied ex vivo, to harvested autologous bone grafts (autograft) to enhance the osteogenic properties of the autograft prior to reimplantation in orthopedic surgeries. This is a phase 1/2 open label safety evaluation of ART352-L treated autologous bone grafts in patients undergoing posterolateral lumbar spinal fusion to treat single level degenerative spondylolisthesis. The primary objective of the study is to evaluate the safety and tolerability of ART352-L treated local bone autografts in patients being treated for this condition, with the secondary objective to evaluate the rates of early and overall spinal fusion. Additionally, changes in patient mobility and quality of life measures from baseline following treatment with ART352-L will be evaluated.

Conditions

• Degenerative Spondylolisthesis

Interventions

Type	Name	Description
BIOLOGICAL	ART352-L	recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures

Timeline

• Start date: 2020-09-30
• Primary completion: 2022-04-01
• Completion: 2023-10-01
• First posted: 2020-05-07
• Last updated: 2020-10-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study