NCT04835389

Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis

A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled trial comparing a single intra-articular injection of 2.0 mL AlloGen vs 2.0 mL sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks.

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled trial comparing a single intra-articular 2.0 mL injection of either AlloGen or sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks. The patient will remain blinded to his or her treatment throughout the study duration. The investigator/assessor will also remain blinded throughout the treatment period. Only the individual(s) preparing the injection will not be blinded. Black tape over the injection syringe will mask the study treatment. Up to 30 adult patients with osteoarthritis of one knee that has failed to adequately respond to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen, will be enrolled at up to 5 sites in the US. The first 6 subjects will be staggered to evaluate any significant toxicity. Any adverse event data collected will be reviewed by the Data Safety Monitoring Board (DSMB) prior to treating the subsequent subject. Cumulative safety data from these 6 subjects will be reviewed by the DSMB.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	AlloGen Liquid	Amniotic fluid
DRUG	Placebo	0.9% normal saline

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-03-01
• Completion: 2022-06-30
• First posted: 2021-04-08
• Last updated: 2021-07-08

Regulatory

• FDA-regulated drug study