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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-02

Study Completion Date

2023-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Platelet-rich Plasma

Intervention Type BIOLOGICAL

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 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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Conditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance.

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.

Group Type EXPERIMENTAL

Low Molecular Weight Hyaluronic Acid

Intervention Type DRUG

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

Interventions

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Platelet-rich Plasma

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

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Low Molecular Weight Hyaluronic Acid

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

Intervention Type DRUG

Other Intervention Names

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PRP Conditioned Medium UC-MSCs Secretome HA

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No