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| Name | Class |
|---|---|
| Dr. Mohammad Hoesin Central General Hospital | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich Plasma (PRP) | Experimental | 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. |
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| Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome | Experimental | 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. |
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| Hyaluronic Acid (HA) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich Plasma | Biological | Research participants own blood will be used to prepare the platelet rich plasma injectate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | Pre-Treatment |
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 3 months after the fifth once-weekly injection. |
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 6 months after the fifth once-weekly injection. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | Pre-Treatment |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | 3 months after the fifth once-weekly injection |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Assessment | Cartilage Oligomeric Matrix Protein (COMP) | Pre-Treatment |
| Laboratory Assessment | Cartilage Oligomeric Matrix Protein (COMP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radiyati U Partan, MD | Universitas Sriwijaya | Principal Investigator |
| Surya Darma, MD | Universitas Sriwijaya | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Hoesin Central General HospitalPalembang | Palembang | South Sumatera | 30114 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23104611 | Background | Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25. | |
| 25624776 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 1, 2022 |
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| Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome | Biological | Conditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance. |
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| Low Molecular Weight Hyaluronic Acid | Drug | low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance. |
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| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | 6 months after the fifth once-weekly injection |
| 3 months after the fifth once-weekly injection |
| 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 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015. |
| 27384560 | Background | Montanez-Heredia E, Irizar S, Huertas PJ, Otero E, Del Valle M, Prat I, Diaz-Gallardo MS, Peran M, Marchal JA, Hernandez-Lamas Mdel C. Intra-Articular Injections of Platelet-Rich Plasma versus Hyaluronic Acid in the Treatment of Osteoarthritic Knee Pain: A Randomized Clinical Trial in the Context of the Spanish National Health Care System. Int J Mol Sci. 2016 Jul 2;17(7):1064. doi: 10.3390/ijms17071064. |
| 23270598 | Background | Magnussen RA, Flanigan DC, Pedroza AD, Heinlein KA, Kaeding CC. Platelet rich plasma use in allograft ACL reconstructions: two-year clinical results of a MOON cohort study. Knee. 2013 Aug;20(4):277-80. doi: 10.1016/j.knee.2012.12.001. Epub 2012 Dec 24. |
| 35298024 | Background | Ossendorff R, Walter SG, Schildberg FA, Khoury M, Salzmann GM. Controversies in regenerative medicine: should knee joint osteoarthritis be treated with mesenchymal stromal cells? Eur Cell Mater. 2022 Mar 17;43:98-111. doi: 10.22203/eCM.v043a09. |
| 22534958 | Background | Gosens T, Den Oudsten BL, Fievez E, van 't Spijker P, Fievez A. Pain and activity levels before and after platelet-rich plasma injection treatment of patellar tendinopathy: a prospective cohort study and the influence of previous treatments. Int Orthop. 2012 Sep;36(9):1941-6. doi: 10.1007/s00264-012-1540-7. Epub 2012 Apr 27. |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Platelet-Rich Plasma (PRP): ~15 participants UC-MSCs Secretome: ~15 participants Hyaluronic Acid (HA): ~15 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-Rich Plasma (PRP) | 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. |
| BG001 | UC-MSCs Secretome | 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 |
| BG002 | Hyaluronic Acid (HA) | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Gender | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| Physical Activity | Count of Participants | Participants |
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| Kellgren Lawrence Grade | Grade 0: No radiographic features of osteoarthritis Grade 1: Doubtful joint space narrowing and possible osteophytic lipping Grade 2: Definite osteophytes and possible narrowing of joint space Grade 3: Multiple moderate osteophytes, definite narrowing of joint space, some sclerosis, possible deformity of bone ends Grade 4: Large osteophytes, marked narrowing of joint space, severe sclerosis, definite deformity of bone ends | Count of Participants | Participants |
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| Serum 25(OH)D Level | Description of Measure: Vitamin D status was defined according to serum 25-hydroxyvitamin D [25(OH)D] concentration: Deficient <20 ng/mL (<50 nmol/L); Insufficient 20-29 ng/mL (50-74 nmol/L); Sufficient ≥30 ng/mL (≥75 nmol/L). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | Posted | Mean | 95% Confidence Interval | points (1-10; higher = worse pain) | Pre-Treatment |
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| Primary | Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | Posted | Mean | 95% Confidence Interval | score 1(good)-10(worst) | 3 months after the fifth once-weekly injection. |
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| Primary | Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | Posted | Mean | 95% Confidence Interval | score 1(good)-10(worst) | 6 months after the fifth once-weekly injection. |
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| Primary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | Posted | Mean | 95% Confidence Interval | scores on a scale | Pre-Treatment |
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| Primary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | Posted | Mean | 95% Confidence Interval | scores on a scale | 3 months after the fifth once-weekly injection |
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| Primary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. | Posted | Mean | 95% Confidence Interval | scores on a scale | 6 months after the fifth once-weekly injection |
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| Secondary | Laboratory Assessment | Cartilage Oligomeric Matrix Protein (COMP) | Posted | Mean | Standard Error | µg/ml | Pre-Treatment |
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| Secondary | Laboratory Assessment | Cartilage Oligomeric Matrix Protein (COMP) | Posted | Mean | Standard Deviation | µg/ml | 3 months after the fifth once-weekly injection |
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From the first study treatment through the final follow-up visit at 24 weeks (6 months) after the first injection.
Adverse events were monitored continuously from the first study treatment through the 24-week follow-up period. Monitoring included assessment at each injection visit and follow-up visit, as well as participant self-reporting of new or worsening symptoms at any time. All reported events were evaluated by a Rheumatology Consultant Internal Medicine Specialist for severity and relationship to the study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platelet-Rich Plasma (PRP) Injections | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Conditioned Medium UC-MSCs Injections | 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 weeks. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Hyaluronic Acid Injections | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Radiyati Umi Partan | Division of Rheumatology, Internal Medicine Department, Faculty of Medicine, Sriwijaya University- Dr. Moh. Hoesin Hospital, Palembang, Indonesia | 0 | radiyati.u.p@fk.unsri.ac.id; |
| Oct 8, 2022 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2023 | Sep 5, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D055442 | Metabolome |
| D008660 | Metabolism |
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