Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment … (NCT05579665) | Clinical Trial Compass
CompletedPhase 1/2
Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Indonesia45 participantsStarted 2022-10-02
Plain-language 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
Who can participate
Age range
30 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS)
Timeframe: Pre-Treatment
2
Visual Analog Scale (VAS)
Timeframe: 3 months after the fifth once-weekly injection.
3
Visual Analog Scale (VAS)
Timeframe: 6 months after the fifth once-weekly injection.
4
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: Pre-Treatment
5
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: 3 months after the fifth once-weekly injection
6
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: 6 months after the fifth once-weekly injection