CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
Hyaluronan +1 moredrug
Likely dose
Not stated in 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.

Search/NCT03889925
NCT03889925Phase 3Completed

Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis

Andrews Research & Education Foundation·interventional·Posted Mar 26, 2019·Updated Feb 24, 2025

In Brief

A Phase 3 clinical trial evaluating Hyaluronan and Autologous conditioned plasma for Knee Osteoarthritis. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but effects are short lived. This has led to the development of additional injection options such as autologous derived blood products which have been documented to alleviate symptoms related to knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting effect with these blood derived products like platelet rich plasma (PRP) \[2-8\]. One clinically-developed preparation of platelet rich plasma, named autologous conditioned plasma (ACP), has randomized controlled trial data proving efficacy \[4,9\]. Clinical use of platelet rich plasma for knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an injection once a week for three weeks. The main objective of this study is to determine if hyaluronic acid (HA) injected at the same time as autologous conditioned plasma (ACP), a leukocyte-poor platelet rich plasma product, will improve the performance of ACP in the treatment of symptomatic knee osteoarthritis. It is hypothesized that the injection of hyaluronic acid will improve the efficacy of ACP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartMar 15, 2019
Primary CompletionOct 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.3 years ago

Interventions

Hyaluronandrug

Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.

Autologous conditioned plasmabiological

Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.