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

Degenerative Spondylolisthesis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04378543
Study type Interventional
Source Ankasa Regenerative Therapeutics, Inc.
Contact Gloria Matthews, DVM, PhD
Phone 404-947-6472
Email gmatthews@wnt3.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 30, 2020
Completion date October 2023
View Details
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