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

NCT04835389 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-07-08

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

AlloGen Liquid

Amniotic fluid

DRUG

Placebo

0.9% normal saline

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • VIVEX Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Cole, MD · Brian Cole MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-03-01
Completion
2022-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04835389 on ClinicalTrials.gov