Mohammad Hoesin Central General HospitalPalembang
Palembang, South Sumatera, 30114, Indonesia
NCT Number: NCT05579665
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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Notify Me30 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Palembang, South Sumatera, 30114, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Research participants own blood will be used to prepare the platelet rich plasma injectate.
Other names: PRP
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 which will be injected into the affected knee using ultrasound guidance.
Other names: HA
Time frame: Pre-Treatment
To asses pain score, score 1(good)-10(worst)
Time frame: 3 months after the fifth once-weekly injection.
To asses pain score, score 1(good)-10(worst)
Time frame: 6 months after the fifth once-weekly injection.
To asses pain score, score 1(good)-10(worst)
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.
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.
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.
Time frame: Pre-Treatment
Cartilage Oligomeric Matrix Protein (COMP)
Time frame: 3 months after the fifth once-weekly injection
Cartilage Oligomeric Matrix Protein (COMP)
Universitas Sriwijaya
Other
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
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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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