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

October 30, 2023 updated by: Universitas Sriwijaya

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30114
        • Mohammad Hoesin Central General HospitalPalembang

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

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-rich Plasma (PRP)
Platelet-rich plasma administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 3mL in volume.
Biological: Platelet-rich Plasma
Research participants own blood will be used to prepare the platelet rich plasma injectate.
Other Names:
  • PRP
Experimental: Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome
Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome averaging 2 mL in volume.
Biological: Conditioned 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.
Other Names:
  • Conditioned Medium UC-MSCs Secretome
Experimental: Hyaluronic Acid (HA)
Hyaluronic Acid administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are of low molecular weight hyaluronan in a 2mL injection.
Drug: Low Molecular Weight Hyaluronic Acid
low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.
Other Names:
  • HA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 3 month after injection
To asses pain score, score 1(good)-10(worst)
3 month after injection
Visual Analog Scale (VAS)
Time Frame: 6 month after injection
To asses pain score, score 1(good)-10(worst)
6 month after injection
Visual Analog Scale (VAS)
Time Frame: Pre-Treatment
To asses pain score, score 1(good)-10(worst)
Pre-Treatment
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 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.
Pre-Treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 3 month after injection
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.
3 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 6 month after injection
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.
6 month after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory Assessment
Time Frame: Pre-Treatment
Cartilage Oligomeric Matrix Protein (COMP)
Pre-Treatment
Laboratory Assessment
Time Frame: 3 month after injection
Cartilage Oligomeric Matrix Protein (COMP)
3 month after injection

Collaborators and Investigators

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

Sponsor

Universitas Sriwijaya

Collaborators

Dr. Mohammad Hoesin Central General Hospital

Investigators

  • Principal Investigator: Radiyati U Partan, MD, Universitas Sriwijaya
  • Study Director: Surya Darma, MD, Universitas Sriwijaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 2, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58/kepkrsmh/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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