MedTrace Logo

Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis

NCT03889925 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-24

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Hyaluronan

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.

BIOLOGICAL

Autologous conditioned plasma

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

Sponsors & Collaborators

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Adam Anz, MD · Andrews Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2022-10-17
Completion
2022-10-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889925 on ClinicalTrials.gov