At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 447 enrolled
Drug / intervention
Micronized dHACM +1 morebiological
Likely dose
Micronized dHACM 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee
In Brief
A Phase 2 clinical trial evaluating Micronized dHACM and Saline for Knee Osteoarthritis. Completed, enrolled 447 participants across 17 sites.
Detailed Summary
The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartMar 2018
First PostedApr 2018
Primary CompletionApr 2022
TodayJul 2026
First PostedApr 2, 2018
Enrollment StartMar 27, 2018
Primary CompletionApr 19, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.3 years ago
Interventions
Micronized dHACMbiological
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
Salinedrug
Injection of 1 mL 0.9% Sodium Chloride, USP