Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis

Comparative Effectiveness of Platelet Rich Plasma (PRP), Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome and Hyaluronic Acid (HA) for the Treatment of Knee Osteoarthritis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05579665

Enrollment

Registered

2022-10-14

Start date

2022-10-02

Completion date

2023-05-31

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

The clinical trial will be carried out at the Dr. Moh. Hoesin Central Hospital, Palembang and planned from October 2022 to March 2023. This study aims to compare the efficacy of Platelet Rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome and hyaluronic acid for the Treatment of Knee Osteoarthritis

Detailed description

In this, prospective, Open-label study, patients with mild to moderate symptomatic knee osteoarthritis will be randomized to receive either a series of platelet-rich plasma or hyaluronic acid or Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome injections under ultrasound guidance. Each of the groups were given 5 times injection 3 cc platelet-rich plasma or 2 cc hyaluronic acid or 2cc Conditioned Medium From Umbilical Cord MSC Secretome at intervals 1 weeks. Clinical data in the form of subjective outcome measures will be collected pre-treatment and 6 months after injection.

Interventions

BIOLOGICALConditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome

Conditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance.

BIOLOGICALPlatelet-rich Plasma

Research participants own blood will be used to prepare the platelet rich plasma injectate.

DRUGLow Molecular Weight Hyaluronic Acid

low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients aged 30-60 years * Suffering from grade 2 and 3 osteoarthritis (OA) was identified by two observers who differed accordingly the Kellgren and Lawrence research scale * Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inﬂammatory medications and that deteriorated with weight-bearing * Patients can understand the nature of the study and written informed consent is given to patients

Exclusion criteria

* Age \> 60 years * Acute Knee Osteoarthritis Effusions * Patients are not willing to obey the study protocol * There are signs of infection local or general infection or positive serology for HIV, hepatitis and syphilis * There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results * Articular injection of the knee by any drug during the previous 3 months * Participate in any clinical trial or treatment 30 days before the study * Other conditions may, according to medical criteria, not support participation in this research (The recent history of knee trauma, Autoimmune rheumatic diseases, Uncontrolled systemic diseases such as diabetes or hypertension, patient with Immunosuppressive or anticoagulant treatment and cancer)

Design outcomes

Primary

Measure	Time frame	Description
Visual Analog Scale (VAS)	Pre-Treatment	To asses pain score, score 1(good)-10(worst)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Pre-Treatment	To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (0-20), stiffness (0-8), and physical function (0-68). Each item is scored on a Likert scale, and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitation.

Secondary

Measure	Time frame	Description
Laboratory Assessment	Pre-Treatment	Cartilage Oligomeric Matrix Protein (COMP)

Countries

Indonesia

Contacts

PRINCIPAL_INVESTIGATORRadiyati U Partan, MD

Universitas Sriwijaya

STUDY_DIRECTORSurya Darma, MD