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

Universitas Sriwijaya45 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Platelet-rich PlasmaBIOLOGICAL

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

Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) SecretomeBIOLOGICAL

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

Low Molecular Weight Hyaluronic AcidDRUG

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

Mohammad Hoesin Central General HospitalPalembang

Palembang, South Sumatera, Indonesia

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

To asses pain score, score 1(good)-10(worst)

Time frame: Pre-Treatment

Visual Analog Scale (VAS)

To asses pain score, score 1(good)-10(worst)

Time frame: 3 month after injection

Visual Analog Scale (VAS)

To asses pain score, score 1(good)-10(worst)

Time frame: 6 month after injection

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The WOMAC is a self administered questionnaire consisting of 24 items divided into subscales including pain (0-20), stiffness (0-8) and physical function (0-68). Higher scores indicate worse pain, stiffness and functional limitations.

Time frame: Pre-Treatment

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time frame: 3 month after injection

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes