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

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: Not yet recruiting
• Conditions: Knee Arthritis Osteoarthritis; Platelet Rich Plasma Injection; Conditioned Serum
• Intervention / Treatment: Drug: Autologous Platelet-Rich Plasma (PRP); Drug: Conditioned serum (CS)

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GÜLİN FINDIKOĞLU, Professor, MD, PhD; Phone Number: +905334227076; Email: gulin_dr@yahoo.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual pain scale score	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

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: knee osteoarthritis; inflammation; cartilage; platelet rich plasma injection; conditioned serum injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Pathological Conditions, Signs and Symptoms; Osteoarthritis, Knee; Inflammation
• Other Study ID 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