Trial Profile
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
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 13 Dec 2023
Price :
$35
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At a glance
- Drugs DHACM (Primary)
- Indications Musculoskeletal pain; Osteoarthritis
- Focus Adverse reactions; Therapeutic Use
- Sponsors MiMedx
- 02 Jun 2022 According to a MiMedx media release, the studies were not designed with stopping rules for effectiveness or failure, but to assess the adequacy of the planned sample sizes, an appropriate approach for studies in these indications and of this novelty
- 02 Jun 2022 According to a MiMedx media release, under the highly regulated and closely monitored clinical trial procedures, MIMEDX was required, based on the studys planned blinded interim analysis, to decide between expanding the trial to capture more data, increasing the power to observe statistically and clinically significant results, or proceeding with the existing patient cohort size.
- 02 Jun 2022 According to a MiMedx media release, Prescience Point falsely implies that MIMEDX had an opportunity to stop the Phase 2B KOA trial of its micronized dehydrated human amnion chorion membrane product.