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

NCT05579665 | Completed Phase 1

• 1 other identifier: 58/kepkrsmh/2022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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 month after injection

• Visual Analog Scale (VAS)

  To asses pain score, score 1(good)-10(worst)

  6 month after 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 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

• 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

• 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 Outcomes (2)

• Laboratory Assessment

  Pre-Treatment

• Laboratory Assessment

  3 month after injection

Study Arms (3)

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.

Biological: Platelet-rich Plasma

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.

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

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.

Drug: Low Molecular Weight Hyaluronic Acid

Interventions

Platelet-rich Plasma BIOLOGICAL

Research participants own blood will be used to prepare the platelet rich plasma injectate.

Also known as: PRP

Platelet-rich Plasma (PRP)

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.

Also known as: Conditioned Medium UC-MSCs Secretome

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

Low Molecular Weight Hyaluronic Acid DRUG

low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.

Also known as: HA

Hyaluronic Acid (HA)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• Dr. Mohammad Hoesin Central General Hospital: collaborator

Study Sites (1)

Mohammad Hoesin Central General HospitalPalembang

Palembang, South Sumatera, 30114, Indonesia

Location

Related 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.

  PMID: 23104611 BACKGROUND

• 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.

  PMID: 25624776 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.

  PMID: 27384560 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.

  PMID: 23270598 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.

  PMID: 35298024 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.

  PMID: 22534958 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Secretome

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Metabolome; Metabolism

Study Officials

• Radiyati U Partan, MD

  Universitas Sriwijaya

  PRINCIPAL INVESTIGATOR

• Surya Darma, MD

  Universitas Sriwijaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 14, 2022
• Study Start: October 2, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)