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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients between the ages of 30 and 80.

- Documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the involved knee (Kellgren-Lawrence grades 1-4) - Patients must have a documented diagnosis of primary OA for at least 6 weeks.

Exclusion Criteria:

- Patients who have had viscosupplementation in the involved knee in the past 6 months.

- Any patient who has had a corticosteroid injection in any joint within 3-months prior to screening will be excluded.

- Patients with gout or rheumatologic disease will be excluded.

Patients who have had a previous negative experience with HA.

- Any patient who will have difficulty obtaining internet access, does not have an active e-mail address, or is unable to comprehend study documents or give informed consent will be excluded.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03889925
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Andrews Research & Education Foundation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Arms & Interventions

Arms

Experimental: Autologous conditioned plasma group

Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.

Experimental: Autologous conditioned plasma with hyaluronic acid group

Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.

Interventions

Drug: - Hymovis

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gulf Breeze, Florida

Status

Address

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561

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