Recruiting

ArtiBest Intra-Articular Injection for Knee Osteoarthritis Pain Relief

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What is being tested

ArtiBest ® Intra articular Injection

Device
Who is being recruted

From 35 to 85 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorMaxigen Biotech Inc.
Study ContactChen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 11, 2025

Actual date on which the first participant was enrolled.

This study is focused on evaluating a treatment for knee osteoarthritis using a product called ArtiBest®, which is an injection containing sodium hyaluronate. The goal is to determine how effective and safe this treatment is for individuals suffering from knee osteoarthritis. Around 60 patients are expected to participate, each receiving an injection into their knee joint. This study is significant because knee osteoarthritis can cause significant pain and mobility issues, and finding a reliable treatment can greatly improve the quality of life for those affected. Participants in the study will receive a single injection of ArtiBest® directly into their knee. Researchers will monitor the participants' progress through follow-up visits at 4 weeks, 12 weeks, and 26 weeks after the injection. They will measure changes in the participants' knee pain and function, as well as the range of motion of the knee. Additionally, the study will analyze changes in the joint space and cartilage condition over time. The results will be evaluated using specific statistical tests to determine the treatment's effectiveness. This approach aims to provide detailed insights into how the treatment impacts knee health over a longer period.

Official TitleIntra Articular Hyaluronic Acid (ArtiBest ® ) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
NCT06994546
Principal SponsorMaxigen Biotech Inc.
Study ContactChen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Age from 35 to 85 years.
Subject with x ray imaging evidence of knee OA as Kellgren Lawrence grade = 2 or 3 within 1 month at screening.
Subject diagnosed with mild to moderate knee OA, particularly in patients who failed to respond adequately to conservative nonpharmacologic therapies or analgesics.
Subject with a 100 mm VAS resting pain score ≥ 30 mm in the studied knee at both the screening and treatment visit (screening visit and treatment visit can be on the same day)
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7 exclusion criteria prevent from participating
Subjects with known hypersensitivity to hyaluronate.
Subjects with infections or skin diseases in the area of the injection site.
Pregnancy or breast feeding woman.
Joining other interventional trial s within 3 months prior to injecting this study product
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, TaiwanOpen Kaohsiung Chang Gung Memorial Hospital in Google Maps
Recruiting
One Study Center