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Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis

NCT05092646 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-02-08

No results posted yet for this study

Summary

A Double-blind, Multi-Center, Prospective, Randomized Placebo-controlled Pilot Study Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects with Ankle Osteoarthritis. The goal of this pilot study and subsequent pivotal trial is to evaluate the safety and effectiveness of Axolotl Ambient intra-articular injection for ameliorating the pain and dysfunction associated with ankle OA.

Conditions

  • Ankle Osteoarthritis

Interventions

BIOLOGICAL

Axolotl Ambient

Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.

DRUG

"Drug/Placebo: 0.9% Normal Saline"

"Drug/Placebo: 0.9% Normal Saline"

Sponsors & Collaborators

  • Axolotl Biologix

    lead INDUSTRY

Principal Investigators

  • Robert S. Kellar, PhD · Chief Science Officer (CSO)

  • Aaron J. Tabor, PhD, CTBS · V.P. of Clinical Operations

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-11-10
Completion
2023-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05092646 on ClinicalTrials.gov