Comparison of Platelet-rich Plasma and Activated Cytokine-rich Serum Injection Treatments in Patients With Knee Osteoarthritis. (KOA PRP ACS) (KOA PRP ACS)

March 16, 2026 updated by: GULIN FINDIKOGLU, Pamukkale University
The effects of single dose injection of platelet rich plasma or conditioned serum in the knee joint in patients with knee osteoarthritis will be compared

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with early grade bilateral knee osteoarthritis (Kellgren Lawrence grade 1 or 2) will be divided into 2 groups. One group of patients will be injected with single dose of autologous platelet rich plasma (PRP) in the knee joints. Other group of patients will be injected with eqiuvolume of autologous conditioned serum (CS) (also known as activated cytokine rich serum) in the knee joints. Patients' serum before injection, the treatment product (PRP and CS), patients serum 30 min after injection will be investigated for IL-1β, IL-1Ra, PDGF-BB, IGF-1, TGF-β and TNF-α. Patients' serum 1 week and 1 month after injection will be investigated for MMP-13, COMP by ELISA. Patients will also be investigated for visual pain scale, WOMAC (Western Ontorino and Mc Master) scale range of motion, ultrasonographic tibiofemoral cartilage thickness measurement and functional tests including the 30-second chair test, stair climb test, 40 meter fast paced walk test, timed up and go test, 6-minute walk test, and walking speed in the first week, first month and third month after injection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: GÜLİN FINDIKOĞLU, Professor, MD, PhD
  • Phone Number: +905334227076
  • Email: gulin_dr@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of knee osteoarthritis according to ACR criteria at least 6 months ago.
  2. Being between grade 1-2 according to the Kellgren-Lawrence radiological classification.
  3. Not having had PRP injection in the last year.
  4. Knee pain ≥ 5 according to the visual pain scale.

Exclusion Criteria:

  1. Those with significant neurological or cardiovascular disorders.
  2. Those with active thrombovascular disease.
  3. Those with joint or skin infections.
  4. Those who have recently had an infectious disease.
  5. Those infected with Hepatitis B, C, and HIV.
  6. Those who have received intra-articular knee injections (hyaluronic acid, PRP, corticosteroids, and others) within the last year.
  7. Those who use oral corticosteroids.
  8. Those who have used NSAIDs within the last week.
  9. Those who have used anti-platelet or anti-aggregant drugs within the last week.
  10. Those with coagulation disorders.
  11. Those with hemoglobin <10 g/dl and platelet count <100,000
  12. Those with cancer.
  13. Pregnant or breastfeeding women, drug addicts.
  14. Those scheduled for knee surgery or arthroscopy, or those who have undergone knee surgery or arthroscopy.

  15. Those with diseases causing secondary osteoarthritis:

    1. post-traumatic,

    2. congenital or developmental diseases

      1. Local diseases (leg length discrepancy, varus, valgus deformities, hypermobility syndromes, scoliosis)
      2. Generalized diseases (Bone dysplasias, Metabolic disorders (hemochromatosis, ochronosis, Gaucher disease, hemoglobinopathy, Ehlers-Danlos disease))
    3. Calcium storage diseases (calcium pyrophosphate storage disease, etc.)
    4. Other bone and joint diseases (avascular necrosis, rheumatoid arthritis, gouty arthritis, septic arthritis, Paget's disease, osteoporosis, osteochondritis)

    5. Other diseases

      1. Endocrine diseases (Diabetes mellitus, acromegaly, hypothyroidism, hyperthyroidism)
      2. Neuropathic arthropathy (Charcot joint)
      3. Other (Frost, Kashin-Beck disease, Caisson disease) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRP group
patients with knee osteoarthritis who will be injected with autologous PRP
Drug: Autologous Platelet-Rich Plasma (PRP)
Autologous Platelet-Rich Plasma (PRP) will be injected intra-articularly in patients with knee osteoarthritis
Experimental: conditioned serum group
patients with knee osteoarthritis who will be injected with autologous conditioned serum
Drug: Conditioned serum (CS)
Autologous conditionedserum (CS) will be injected intra-articularly in patients with knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual pain scale score
Time Frame: Visual pain scale score (min 0-max 10) will be measured at the beginning ofthe study, 1 week, 1month and 3 months after the injection.
Visual pain scale score (min 0-max 10), higher scores indicate better results
Visual pain scale score (min 0-max 10) will be measured at the beginning ofthe study, 1 week, 1month and 3 months after the injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-60116787-020- 61586
  • 2025TIPF037 (Other Grant/Funding Number: PAU BAP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will bw shared by the primary investigator upon personel contact.

IPD Sharing Time Frame

IPD will be shared until 3 years after the publication.

IPD Sharing Access Criteria

Researchers will be able to access upon personel caontavt by e-mail of the primary investgator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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