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Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:
Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain

Clinical Trial Summary

To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.

Clinical Trial Description

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03074526
Study type Interventional
Source MiMedx Group, Inc.
Contact
Status Completed
Phase N/A
Start date January 23, 2017
Completion date April 25, 2018
View Details
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