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
Phase: PHASE1
Conditions: Knee Osteoarthritis
Sponsor: Universitas Sriwijaya

STUDY PROTOCOL OUTLINE 
 
NCT NUMBER  
: PENDING 
 
TITLE 
 
 
: Effectiveness of Platelet Rich Plasma, 
Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell 
Culture (MSCs) Secretome and hyaluronic acid for the Treatment 
of  Knee Osteoarthritis 
 
DATE of DOCUMENT : OCTOBER 1, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ABBREVIATIONS 
 
COMP  
: Cartilage Olligometric Matrix Protein 
FAS 
 
: Full Analysed Set 
HA 
 
: Hyaluronic Acid 
HIV 
 
: Human Immunodeficiency Virus 
OA  
 
: Osteoarthritis  
PRP 
 
: Platelet Rich Plasma 
RSMH  
: RSUP Mohammad Hoesin  
UC MSCs  
: Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) 
USG  
: Ultrasonography 
VAS 
 : Visual Analog Scale 
WOMAC 
: The Western Ontario and McMaster Universities Index 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
1. Abstract 
Osteoarthritis (OA) is defined as progressive destruction of the articular cartilage with 
subchondral bone thickening, osteophyte formation, and mild chronic inflammation of 
the synovium. The prevalence of osteoarthritis in the world is relatively high and is one 
of the most common musculoskeletal diseases. Based on the RSMH Rheumatology 
Division annual report, osteoarthritis is the most common disease treated in the 
rheumatology outpatient clinic. There has been an increase in the number of osteoarthritis 
patients from 2019 to 2021. 
Inflammation in OA is caused by proinflammatory cytokines that can stimulate the 
expression of catabolic enzymes and induce the transformation of subchondral bone and 
articular cartilage. During the process of the articular cartilage matrix turnover, cartilage 
matrix fragments will be released, and the degradation products of another cartilage 
metabolism will be released into the synovial fluid and blood serum. One of the released 
macromolecules is COMP. Thus COMP is a degradation product of articular cartilage 
and can be a diagnostic and prognostic marker in serum for the diagnosis of knee OA. 
One of the treatment techniques for osteoarthritis (OA) is intra-articular injection. 
However, existing intra-articular injection treatment is not optimal, and long-term use of 
painkillers can cause side effects. So, currently, many studies are examining the latest 
treatments that can produce better and longer-lasting functional results, such as Platelet 
Rich Plasma and Mesenchymal Stem Cells Secretome or Secretome. In addition, many 
preclinical to clinical studies and experiments have reported the effectiveness of Platelet 
Rich Plasma, Mesenchymal Stem Cells Secretome and hyaluronan separately for 
improving musculoskeletal diseases, one of which is osteoarthritis. In this study, the two 
therapeutic modalities will be compared together so that the effectiveness of 
administration in knee OA patients will be determined by knowing the changes in the 
degree of pain (WOMAC and VAS) and the condition of the joint cartilage with changes 
in the COMP marker concentration. 
 

Method: 
The design of this study was experimental with a clinical trial design, randomized and 
open-label. 
Expected results: 
It will be known how the effectiveness of giving secretome and hyaluronic acid in patients 
with knee osteoarthritis. The doctor used the results of this study to consider the 
administration of secretome and hyaluronan in patients with knee osteoarthritis.  
Keywords: 
Knee Osteoarthritis (OA), Secretome, Hyaluronic Acid, Intra-articular Injection 
 
2. Brief Summary 
The clinical trial will be carried out at the Dr. Moh. Hoesin Central Hospital, Palembang 
and planned from October 2022 to March 2023.  
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 
Culture (MSCs) 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 
CM UC MSCs (secretome) at intervals 1 weeks. 
Clinical data in the form of subjective outcome measures will be collected pre-treatment 
and 6 months after injection.  
 
3. Study Design 
Study Type  : 
Interventional  (Clinical Trial) 
Actual Enrollment  : 
45 participants 
Allocation: 
Randomized 
Intervention Model: 
Parallel Assignment 

Masking: 
None (Open Label) 
Primary Purpose: 
Treatment 
Official Title: 
Comparative Effectiveness of Platelet 
Rich Plasma, Conditioned Medium From 
Umbilical Cord Mesenchymal Stem Cell 
Culture (MSCs) Secretome and hyaluronic 
acid 
for 
the 
Treatment 
of  
Knee 
Osteoarthritis  
 
Study Start Date  : 
March 2021 
Actual Primary Completion Date  : 
March 2022 
Actual Study Completion Date  : 
October 2022 
 
4. Arms and Interventions 
Arm  
Intervention/treatment  
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. 
Biological: Hyaluronic Acid 
Experimental: Platelet-rich Plasma (PRP) 
Biological: Platelet-rich 
Plasma (PRP) 

Arm  
Intervention/treatment  
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. 
Experimental: UC MSCs Secretome 
UC-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  
 
5. Outcome Measures 
Primary Outcome Measures  : 
1. Visual Analog Scale (VAS) [ Time Frame: Pre-Treatment ] 
To asses pain score, score 1(good)-10(worst) 
2. Visual Analog Scale (VAS) [ Time Frame: 3 month after injection ] 
To asses pain score, score 1(good)-10(worst) 
3. Visual Analog Scale (VAS) [ Time Frame: 6 month after injection ] 
To asses pain score, score 1(good)-10(worst) 
4. Western 
Ontario 
and 
McMaster 
Universities 
Osteoarthritis 
Index 
[ 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. 
5. Western Ontario and McMaster Universities Osteoarthritis Index [ 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. 
6. Western Ontario and McMaster Universities Osteoarthritis Index [ 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. 
 
Secondary Outcome Measures   
1. Laboratory Asessment [ Time Frame: Pre-Treatment ] 
COMP 
2. Laboratory Asessment [ Time Frame: 3 monts after injection ] 
COMP 
 
6. Eligibility Criteria 
Ages Eligible for Study:    
30 Years to 60 Years   (Adult, Older Adult) 
Sexes Eligible for Study:    
All 
Accepts Healthy Volunteers:    
No 
 

Criteria 
Inclusion Criteria: 
• Patients aged 30-60 years 
• Suffering from grade 2 and 3 OA was identified by two observers who differed 
accordingly Kellgren-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-
bearin 
• Patients can understand the nature of the study and written informed consent is 
given to patients 
Exclusion Criteria: 
• Age > 60 years 
• Acute Knee Osteoathritis 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. 
 
 
 
 

7. Flow Diagram (Randomized Contrroled Trial) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. Safety Monitoring Plan 
Complications are rare but may include injection site pain, septic arthritis, hemarthrosis, 
and allergic reactions. This study will minimize this by ensuring the correct injection 
Screm potensial participants by incusion and exclusion criteria 
Randomize 
Arm 1: Platelet Rich 
Plasma Injection (PRP) 
Arm 3: Hyaluronic 
Acid Injection 
Arm 2: UC-MSCs 
Secretome Injection 
Perform baseline assesment  
(Pre-Treatmenet): VAS, WOMAC and 
COMP Level 
Prior to 
Enrollment 
Each PRP, UC-MSCs Secretome and Hyaluronic acid 
were administered five times as an intra-articular 
injection under ultrasound guidance as a series of one 
weekly injections to the affected knee. 
 
Time Point  
After 3 months, perform final assesment 
VAS, WOMAC and COMP Level 

location using an ultrasound (USG); disinfectant in the injection area, and the injection 
will be carried out by a Rheumatology Consultant Internal Medicine Specialist. 
 
In case of complications related to intra-articular injections, research subjects can come 
for a consultation to RSMH with medical expenses using the subject's health insurance 
or borne by the research team if the subject does not have health insurance. 
 
9. Analysis Plan 
The design of this study was experimental with a clinical trial design, randomized and 
open-label. The full analysis set (FAS) will include all subjects who were randomized to 
study treatment. Analyses performed on the FAS will take into account subjects 
allocation to treatment groups as randomized. Clinical data in the form of subjective 
outcome measures will be collected pre-treatment and 6 months after injection.  
 
10. Literatured Cited 
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Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra- 
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40:2822-2827. 
2. Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, 
Azma K. Knee osteoarthritis injection choices: Platelet-rich plasma (PRP) versus 
hyaluronic acid (a one-year randomized clinical trial). Clin Med Insights Arthritis 
Musculoskelet Disord 2015; 8:1-8. 
3. Sánchez M, Anitua E, Azofra J, Prado R, Muruzabal F, Andia I. Ligamentization 
of tendon grafts treated with an endogenous preparation rich in growth factors: 
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4. Krych AJ, Nawabi DH, Farshad-Amacker NA, Jones KJ, Maak TG, Potter HG, 
Williams RJ 3rd. Bone marrow concentrate improves early cartilage phase 
maturation of a scaffold plug in the knee: A comparative magnetic resonance 

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5. Montañez-Heredia E, Irízar S, Huertas PJ, Otero E, Del Valle M, Prat I, Díaz- 
Gallardo MS, Perán M, Marchal JA, Hernandez- Lamas Mdel C. Intra-
articularinjections of platelet-rich plasma versus hyaluronic acid in the treatment 
of osteoarthritic knee pain: A randomized clinical trial in the context of the Spanish 
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2016;17:1064. 
6. Simental-Mendía M, Vílchez-Cavazos JF, Peña-Martínez VM, Said-Fernández S, 
Lara-Arias J, Martínez-Rodríguez HG. Leukocyte-poor platelet-rich plasma is 
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of early knee osteoarthritis. Arch Orthop Trauma Surg 2016; 136:1723-1732. 
7. Evans A, Ibrahima M, Popeb R, Mwangia J, Botrosa M, et,al. Treating hand and 
foot osteoarthritis using a patient's own blood: A systematic review and meta-
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8. de Jonge S, de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, 
Weinans H, Tol JL. One-year follow-up of platelet-rich plasma treatment in 
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9. Gosens T, Den Oudsten BL, Fievez E, van ‘t Spijker P, Fievez A. Pain and activity 
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Int Orthop 2012; 36:1941-1946. 
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12. Murray MM, Spindler KP, Ballard P, Welch TP, Zurakowski D, Nanney LB. 
Enhanced histologic repair in a central wound in the anterior cruciate ligament with 
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Takahashi K. Effects of autologous plateletrich plasma on cell viability and 
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magnetic resonance imaging findings in anterior cruciate ligament grafts with and 
without autologous platelet-derived growth factors. Arthroscopy 2010; 26:50-57. 
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MOON cohort. Knee. 2013 August; 20(4): 277–280 
 
 
 
 
 
 
 
 
 
 
 
 

 
  
 
 
RSMH Palembang 
Jl. Jenderal Sudirman Kilometer 3,5, Palembang 30126 
 
 
 
 
 
Telp: (0711) 354088   Fax: (0711) 351318 Web : www.rsmh.co.id Email : humas.rsmh@gmail.com 
                                                                                                                                                                                       
 
NRM 
 
: 
Nama 
 
: 
Jenis Kelamin 
: 
Tanggal lahir 
: 
    (Mohon diisi atau tempelkan stiker jika ada) 
RM 017B.8 (Revisi IV) 
INFORMED CONSENT 
 
 
I am (Dr. dr. Radiyati Umi Partan, SpPD-KR, M.Kes.) a researcher from (Internal 
Medicine Program, FK UNSRI/RSMH Palembang), with this request you to participate 
voluntarily in the research entitled "(Effectiveness of Platelet-Rich Plasma (PRP), 
Mesenchymal Stem Cells Secretome (Secretome), and Hyaluronic Acid (Umarone) in 
Knee Osteoarthritis Patients) with several explanations as follows: 
 
1. The purpose of this study was to obtain a new therapeutic method by 
injection/injecting drugs into the knee joint. Those who participate in this study will 
receive the latest therapeutic method with intra-articular injection (knee joint 
injection) with the latest therapeutic modality for free. In addition, this research will 
be able to determine a more effective therapeutic modality. 
2. You were involved in the research because it met the criteria required by the 
researcher. Your involvement in this research is voluntary. 
3. If you disagree with this method, you can choose another method, namely resigning, 
or you may not participate in this research. For that, you will not be penalised 
4. This study will last 24 weeks, where five injections will be given at an interval of 1 
week. Patients will be evaluated for pain until the 24th week. 
5. You will not be given a replacement/compensation for lost time/inconvenience 
during the research because this research is voluntary. However, the patient will be 
monitored and given treatment for side effects. 
6. After completing the research, you will be given information about research results 
in general through education and direct delivery of results. 
7. You will get information about your health condition during data collection/sampling 
at the beginning and end of the study. 
8. You will be informed if side effects or unexpected findings are found during this 
study. 
9. You will also be informed of other data related to your situation that may be found 
during sampling/data collection unless the findings are not yet valid. 
10. (Platelet-Rich Plasma (PRP)) The procedure is to take 30 ml of blood and then 
process it in the RSMH Clinical Pathology laboratory and inject it into the painful 
knee; this method may cause a little pain and discomfort that the subject may 
experience from actions received during the study. Pain during injection was 
minimised with a local anaesthetic spray, and there was little chance of harm to the 
subject (or other people, including his family) as a result of participating in the study. 

 
  
 
 
RSMH Palembang 
Jl. Jenderal Sudirman Kilometer 3,5, Palembang 30126 
 
 
 
 
 
Telp: (0711) 354088   Fax: (0711) 351318 Web : www.rsmh.co.id Email : humas.rsmh@gmail.com 
                                                                                                                                                                                       
 
NRM 
 
: 
Nama 
 
: 
Jenis Kelamin 
: 
Tanggal lahir 
: 
    (Mohon diisi atau tempelkan stiker jika ada) 
RM 017B.8 (Revisi IV) 
11. This procedure was carried out five times with an interval of 1 week. Evaluation 
(VAS and WOMAC) was carried out every week for the first five weeks, then the 
12th and 24th weeks. Side effects of administration were carried out throughout the 
study. 
12. (Mesenchymal Stem Cells Secretome (Secretome)) The procedure is to take five 
ml of blood, then Mesenchymal Stem Cells Secretome (Secretome) is injected into 
the affected knee; this method may cause slight pain and discomfort, which may be 
experienced by the subject from the actions received during the study. Pain during 
injection was minimised with a local anaesthetic spray, and there was little chance of 
harm to the subject (or other people, including his family) as a result of participating 
in the study. This procedure was carried out five times with an interval of 1 week. 
Evaluation (VAS and WOMAC) was carried out every week for the first five weeks, 
then the 12th and 24th weeks. Side effects of administration were carried out 
throughout the study. 
13. (Hyaluronan (Umarone)) The procedure is to take five ml of blood, and then 
Hyaluronan (Umarone) is injected into the affected knee; this method may cause 
less pain and discomfort that the subject may experience. Received during the study. 
Pain during injection was minimised with a local anaesthetic spray, and there was 
little chance of harm to the subject (or other people, including his family) as a result 
of participating in the study. This procedure was carried out five times with an 
interval of 1 week. Evaluation (VAS and WOMAC) was carried out every week for 
the first five weeks, then the 12th and 24th weeks. Side effects of administration were 
carried out throughout the study. 
14. The benefit you get from your participation is that clinical improvement is expected 
after treatment. Those who participate in this study will receive the latest therapeutic 
method with intra-articular injection (knee joint injection) with the latest therapeutic 
modality for free. In addition, this research will be able to determine a more effective 
therapeutic modality. 
15. The research was conducted with the hope that it can provide benefits to patients, the 
wider community and the development of science, in this case, the treatment of knee 
osteoarthritis. 
16. After completing this research, you can continue treatment/advanced health services 
at the Rheumatology Poly RSMH Palembang with health insurance (BPJS) or pay if 
the general patient follows the applicable provisions at RSMH. 
17. After receiving treatment or medical treatment as a result of research, you must wait 
until the treatment or health action is legally approved.

 
  
 
 
RSMH Palembang 
Jl. Jenderal Sudirman Kilometer 3,5, Palembang 30126 
 
 
 
 
 
Telp: (0711) 354088   Fax: (0711) 351318 Web : www.rsmh.co.id Email : humas.rsmh@gmail.com 
                                                                                                                                                                                       
 
NRM 
 
: 
Nama 
 
: 
Jenis Kelamin 
: 
Tanggal lahir 
: 
    (Mohon diisi atau tempelkan stiker jika ada) 
RM 017B.8 (Revisi IV) 
 
18. You can use analgesics (painkillers) or other non-pharmacological measures while 
waiting for legal approval. 
19. You will be informed if new information is obtained from this research or other 
sources. 
20. All data in this study will be stored by the researcher and the research team in files 
and research reports. Data will be kept confidential by using a numeric code system 
and the initials of the subject's name. Patient data will be stored and kept confidential 
by the researcher. 
21. All the information you provide in this research will not be disseminated, so its 
confidentiality will be guaranteed. 
22. This research received funding from UNSRI and RSMH, but the funders could not 
access the research data without permission from the researcher. Researchers have 
confirmed that there is no conflict of interest in this case 
23. The researcher and seven members of this study. 
24. During the study, researchers will be responsible for the occurrence of risks that can 
occur, such as septic arthritis and allergic reactions. This study will minimise this by 
ensuring the correct injection location using an ultrasound (USG) disinfectant in the 
injection area, and the injection will be carried out by a Rheumatology Consultant 
Internal Medicine Specialist. 
25. If there are other risks from this research, you can get health services in the form of 
free treatment. For example, if the study has side effects, the patient will be treated 
directly by a specialist rheumatology consultant. Treatment can range from 
outpatient to inpatient, free of charge. 
26. If there is a disability or death due to this research, the researcher considers 
compensation if the cause is directly due to the drug given. 
27. The above follows the existing provisions. 
28. This research has received ethical approval from the KEPK, which provides a letter 
of ethical approval. 
29. You will be provided with information if there is a violation of the implementation 
of this research protocol. If there is a violation, the lead researcher will give a 
warning. 
30. You will get an explanation of the research design and the treatment that will be 
carried out until the research is completed. 
31. All important information will be disclosed during the research, and you have the 
right to withdraw data/information during the research.

 
  
 
 
RSMH Palembang 
Jl. Jenderal Sudirman Kilometer 3,5, Palembang 30126 
 
 
 
 
 
Telp: (0711) 354088   Fax: (0711) 351318 Web : www.rsmh.co.id Email : humas.rsmh@gmail.com 
                                                                                                                                                                                       
 
NRM 
 
: 
Nama 
 
: 
Jenis Kelamin 
: 
Tanggal lahir 
: 
    (Mohon diisi atau tempelkan stiker jika ada) 
RM 017B.8 (Revisi IV) 
 
32. The researcher will keep all examination results confidential and will not be disclosed 
except with your permission. 
33. Research will use your medical records and laboratory results only if you give 
permission. 
34. This study uses your blood sample. Researchers will only use the sample according 
to the purpose of this study, and if there is any remaining sample, it will be destroyed 
so that it is not misused. 
35. This study involved you (a woman of patient age), and you have the right to continue 
to follow this study or withdraw if the study has side effects. 
36. This study involved you (pregnant/breastfeeding women), and you have the right to 
continue to follow this study or withdraw if the study has side effects. 
37. Research involves you as a disaster victim for research purposes and is not related to 
humanitarian assistance that others may provide. 
38. This research was not conducted online and did not use online or digital tools. 
 
I hope you are willing to be a respondent in this study, where you will fill out a 
questionnaire related to the research. Then, after you have read the aims and objectives 
of the research above, I ask you to fill in your name and signature below. 
I agree to participate in this research.  
 
Name  
 : _________________________________________  
 
 
 
Signature 
: _________________________________________  
 
Thank you for your willingness to participate in this research. 
 
 Yours faithfully 
Witness 
 
 
 
 
 Researcher 
 
 
 
.....................  
 
Dr. dr. Radiyati Umi Partan, SpPD, K-R, M.Kes