Trial Outcomes & Findings for Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis (NCT NCT05579665)
NCT ID: NCT05579665
Last Updated: 2026-05-22
Results Overview
To asses pain score, score 1(good)-10(worst)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Pre-Treatment
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
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.
Platelet-rich Plasma: Research participants own blood will be used to prepare the platelet rich plasma injectate.
|
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.
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.
|
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.
Low Molecular Weight Hyaluronic Acid: low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Platelet-Rich Plasma (PRP)
n=15 Participants
Platelet-rich plasma administered 5 times as an intra-articular injection under ultrasound guidance to the affected knee. Injections are leukocyte-poor, buffer/additive-free, single-spin PRP, averaging 3 mL in volume, given once weekly for 5 consecutive weeks.
|
UC-MSCs Secretome
n=15 Participants
Conditioned Medium from Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome administered 5 times as an intra-articular injection under ultrasound guidance to the affected knee. Each injection consists of 2 mL of secretome, given once weekly for 5 consecutive week
|
Hyaluronic Acid (HA)
n=15 Participants
Low molecular weight hyaluronic acid administered 5 times as an intra-articular injection under ultrasound guidance to the affected knee. Each injection consists of 2 mL of HA, given once weekly for 5 consecutive weeks.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
41 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
42 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Gender
Female
|
14 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
42 Participants
n=45 Participants
|
|
Gender
Male
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=45 Participants
|
|
BMI
Normal (18.5-25)
|
3 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
9 Participants
n=45 Participants
|
|
BMI
Overweight (25.1-27)
|
6 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
18 Participants
n=45 Participants
|
|
BMI
Obese (>27)
|
6 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
18 Participants
n=45 Participants
|
|
Physical Activity
Mild
|
5 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
15 Participants
n=45 Participants
|
|
Physical Activity
Moderate
|
10 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
30 Participants
n=45 Participants
|
|
Kellgren Lawrence Grade
Grade 2:
|
7 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
21 Participants
n=45 Participants
|
|
Kellgren Lawrence Grade
Grade 3:
|
8 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
24 Participants
n=45 Participants
|
|
Serum 25(OH)D Level
Insufficiency
|
11 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
30 Participants
n=45 Participants
|
|
Serum 25(OH)D Level
Deficiency
|
4 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
15 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Pre-TreatmentTo asses pain score, score 1(good)-10(worst)
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Visual Analog Scale (VAS)
|
5 points (1-10; higher = worse pain)
Interval 3.0 to 7.0
|
5 points (1-10; higher = worse pain)
Interval 4.0 to 5.0
|
5 points (1-10; higher = worse pain)
Interval 2.0 to 7.0
|
PRIMARY outcome
Timeframe: 3 months after the fifth once-weekly injection.To asses pain score, score 1(good)-10(worst)
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Visual Analog Scale (VAS)
|
2 score 1(good)-10(worst)
Interval 1.0 to 4.0
|
1 score 1(good)-10(worst)
Interval 0.0 to 2.0
|
1 score 1(good)-10(worst)
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: 6 months after the fifth once-weekly injection.To asses pain score, score 1(good)-10(worst)
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Visual Analog Scale (VAS)
|
2 score 1(good)-10(worst)
Interval 1.0 to 4.0
|
1 score 1(good)-10(worst)
Interval 0.0 to 2.0
|
1 score 1(good)-10(worst)
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Pre-TreatmentTo 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.
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
45 scores on a scale
Interval 15.0 to 83.0
|
79 scores on a scale
Interval 64.0 to 93.0
|
46 scores on a scale
Interval 18.0 to 89.0
|
PRIMARY outcome
Timeframe: 3 months after the fifth once-weekly injectionTo 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.
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
24 scores on a scale
Interval 4.0 to 41.0
|
29 scores on a scale
Interval 9.0 to 49.0
|
5 scores on a scale
Interval 0.0 to 20.0
|
PRIMARY outcome
Timeframe: 6 months after the fifth once-weekly injectionTo 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.
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
24 scores on a scale
Interval 4.0 to 41.0
|
29 scores on a scale
Interval 9.0 to 49.0
|
5 scores on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Pre-TreatmentCartilage Oligomeric Matrix Protein (COMP)
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Laboratory Assessment
|
635.40 µg/ml
Standard Error 247.69
|
588.67 µg/ml
Standard Error 142.85
|
588.67 µg/ml
Standard Error 142.85
|
SECONDARY outcome
Timeframe: 3 months after the fifth once-weekly injectionCartilage Oligomeric Matrix Protein (COMP)
Outcome measures
| Measure |
Hyaluronic Acid
n=15 Participants
Hyaluronic Acid Injections
|
Platelet-Rich Plasma
n=15 Participants
Platelet-Rich Plasma Injections
|
Mesenchymal Stem Cells Secretome
n=15 Participants
Mesenchymal Stem Cells Secretome Injections
|
|---|---|---|---|
|
Laboratory Assessment
|
625.60 µg/ml
Standard Deviation 260.19
|
557.67 µg/ml
Standard Deviation 123.71
|
557.67 µg/ml
Standard Deviation 123.71
|
Adverse Events
Platelet-Rich Plasma (PRP) Injections
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conditioned Medium UC-MSCs Injections
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hyaluronic Acid Injections
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Radiyati Umi Partan
Division of Rheumatology, Internal Medicine Department, Faculty of Medicine, Sriwijaya University- Dr. Moh. Hoesin Hospital, Palembang, Indonesia
Phone: 0
Email: [email protected];
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place