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OpenTrials
Completed

NCT Number: NCT05579665

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

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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mohammad Hoesin Central General HospitalPalembang

Palembang, South Sumatera, 30114, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Platelet-Rich Plasma

Biological

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

Other names: PRP

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

Biological

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

Other names: Conditioned Medium UC-MSCs Secretome

Low Molecular Weight Hyaluronic Acid

Drug

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

Other names: HA

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Pre-Treatment

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

  2. Visual Analog Scale (VAS)

    Time frame: 3 months after the fifth once-weekly injection.

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

  3. Visual Analog Scale (VAS)

    Time frame: 6 months after the fifth once-weekly injection.

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

  4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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.

  5. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 3 months after the fifth once-weekly injection

    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 (score range 0-20), stiffness (0-8), and physical function (0-68).

    Each item is scored on a Likert scale (0-4), 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.

  6. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 6 months after the fifth once-weekly injection

    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 (score range 0-20), stiffness (0-8), and physical function (0-68).

    Each item is scored on a Likert scale (0-4), 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 outcomes

  1. Laboratory Assessment

    Time frame: Pre-Treatment

    Cartilage Oligomeric Matrix Protein (COMP)

  2. Laboratory Assessment

    Time frame: 3 months after the fifth once-weekly injection

    Cartilage Oligomeric Matrix Protein (COMP)

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Collaborators

  • Dr. Mohammad Hoesin Central General Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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