Phase 2
N=45
Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT05579665 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Visual Analog Scale (VAS) — 5; 5; 5 points (1-10; higher = worse pain) — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Platelet-rich Plasma (Biological); Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome (Biological); Low Molecular Weight Hyaluronic Acid (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Universitas Sriwijaya
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) |
1; 1; 2 | — |
| PRIMARY Visual Analog Scale (VAS) |
1; 1; 2 | — |
| PRIMARY Visual Analog Scale (VAS) |
1; 1; 2 | — |
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
29; 5; 24 | — |
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
29; 5; 24 | — |
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
29; 5; 24 | — |
| SECONDARY Laboratory Assessment |
557.67; 557.67; 625.60 | — |
| SECONDARY Laboratory Assessment |
557.67; 557.67; 625.60 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05579665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.