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Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Platelet-rich Plasma
Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome
Low Molecular Weight Hyaluronic Acid
Sponsored by
Universitas Sriwijaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mohammad Hoesin Central General HospitalPalembang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Platelet-rich Plasma (PRP)

Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome

Hyaluronic Acid (HA)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
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 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.
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 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.
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 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

Laboratory Assessment
Cartilage Oligomeric Matrix Protein (COMP)
Laboratory Assessment
Cartilage Oligomeric Matrix Protein (COMP)

Full Information

First Posted
October 4, 2022
Last Updated
October 11, 2022
Sponsor
Universitas Sriwijaya
Collaborators
Dr. Mohammad Hoesin Central General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05579665
Brief Title
Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitas Sriwijaya
Collaborators
Dr. Mohammad Hoesin Central General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-rich Plasma (PRP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome
Arm Type
Experimental
Arm Description
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.
Arm Title
Hyaluronic Acid (HA)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich Plasma
Other Intervention Name(s)
PRP
Intervention Description
Research participants own blood will be used to prepare the platelet rich plasma injectate.
Intervention Type
Biological
Intervention Name(s)
Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome
Other Intervention Name(s)
Conditioned Medium UC-MSCs Secretome
Intervention Description
Conditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Low Molecular Weight Hyaluronic Acid
Other Intervention Name(s)
HA
Intervention Description
low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
To asses pain score, score 1(good)-10(worst)
Time Frame
Pre-Treatment
Title
Visual Analog Scale (VAS)
Description
To asses pain score, score 1(good)-10(worst)
Time Frame
3 month after injection
Title
Visual Analog Scale (VAS)
Description
To asses pain score, score 1(good)-10(worst)
Time Frame
6 month after injection
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Pre-Treatment
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
3 month after injection
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
6 month after injection
Secondary Outcome Measure Information:
Title
Laboratory Assessment
Description
Cartilage Oligomeric Matrix Protein (COMP)
Time Frame
Pre-Treatment
Title
Laboratory Assessment
Description
Cartilage Oligomeric Matrix Protein (COMP)
Time Frame
3 month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radiyati U Partan, MD
Organizational Affiliation
Universitas Sriwijaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Surya Darma, MD
Organizational Affiliation
Universitas Sriwijaya
Official's Role
Study Director
Facility Information:
Facility Name
Mohammad Hoesin Central General HospitalPalembang
City
Palembang
State/Province
South Sumatera
ZIP/Postal Code
30114
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23104611
Citation
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.
Results Reference
background
PubMed Identifier
25624776
Citation
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.
Results Reference
background
PubMed Identifier
27384560
Citation
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.
Results Reference
background
PubMed Identifier
23270598
Citation
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.
Results Reference
background
PubMed Identifier
35298024
Citation
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.
Results Reference
background
PubMed Identifier
22534958
Citation
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.
Results Reference
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Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis

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