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

N/A
Waitlist Available
Research Sponsored by MiMedx Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4weeks, 6weeks, 3 months, 16 weeks, 6 months

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.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4weeks, 6weeks, 3 months, 16 weeks, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4weeks, 6weeks, 3 months, 16 weeks, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in Pain
Secondary study objectives
Activity of Daily Living Questionnaire
Knee Injury and Osteoarthritis Outcome Score
Range of Motion
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 4mL amniotic fluidActive Control1 Intervention
Amniotic Fluid: 4mL dose of amniotic fluid
Group II: 4mL2x amniotic fluidActive Control1 Intervention
Amniotic Fluid: 4mL 2x dose of amniotic fluid
Group III: 4mL Saline PlaceboPlacebo Group1 Intervention
Normal Saline

Find a Location

Who is running the clinical trial?

MiMedx Group, Inc.Lead Sponsor
35 Previous Clinical Trials
2,673 Total Patients Enrolled
3 Trials studying Osteoarthritis
550 Patients Enrolled for Osteoarthritis
David Mason, MDStudy DirectorChief Medical Officer
4 Previous Clinical Trials
143 Total Patients Enrolled
~17 spots leftby Dec 2025