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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579665
• Other study ID #: 58/kepkrsmh/2022
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Universitas Sriwijaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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-in?ammatory 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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• 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 UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance.

Drug:
• Low Molecular Weight Hyaluronic Acid
low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.

Locations

Country	Name	City	State
Indonesia	Mohammad Hoesin Central General HospitalPalembang	Palembang	South Sumatera

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Sriwijaya	Dr. Mohammad Hoesin Central General Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	To asses pain score, score 1(good)-10(worst)	Pre-Treatment
Primary	Visual Analog Scale (VAS)	To asses pain score, score 1(good)-10(worst)	3 month after injection
Primary	Visual Analog Scale (VAS)	To asses pain score, score 1(good)-10(worst)	6 month after injection
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 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.	Pre-Treatment
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 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.	3 month after injection
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 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 month after injection
Secondary	Laboratory Assessment	Cartilage Oligomeric Matrix Protein (COMP)	Pre-Treatment
Secondary	Laboratory Assessment	Cartilage Oligomeric Matrix Protein (COMP)	3 month after injection