Actively Recruiting
A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Safety and Efficacy of Intra-articular Filler ALLOHEAL in Patients With Knee Osteoarthritis
Led by Endovision Co., Ltd. · Updated on 2026-04-07
286
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
E
Endovision Co., Ltd.
Lead Sponsor
T
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an intra-articular injectable filler called ALLOHEAL in patients with knee osteoarthritis. This trial aims to show that ALLOHEAL is not less effective than the control device, Conjuran®, in reducing joint pain caused by mechanical friction. The trial focuses on adults aged 40 to 80 years who have been diagnosed with knee osteoarthritis and experience significant knee pain. Participants will receive injections of either ALLOHEAL or the active comparator Conjuran® directly into the knee joint. The study includes a follow-up period of 24 weeks to assess both the safety and pain-relief effects of the treatments. Evaluations will take place at 6, 10, 16, and 24 weeks after the initial injection, with the primary endpoint being the change in knee pain measured by the Visual Analog Scale (VAS) at 16 weeks. During the study, participants will undergo clinical assessments including pain evaluations using the VAS scale. Safety data related to the components of ALLOHEAL, including sodium polynucleotide, chitosan, and type I collagen, will be collected throughout the 24-week period. Participants will need to attend scheduled visits for these assessments and comply with study procedures. The total participation time spans approximately six months.
CONDITIONS
Brief Title
A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 40 to less than 80 years at the time of consent
- Diagnosed with knee osteoarthritis according to American College of Rheumatology guidelines within 24 weeks before or at screening
- Experiencing knee pain for at least 8 weeks
- Kellgren-Lawrence grade I-III severity in the target knee based on X-ray at screening
- Weight-bearing Visual Analog Scale (VAS) score of at least 40 mm in target knee at screening
- Body Mass Index (BMI) less than 35 kg/m² at screening
- Able to walk without assistive devices or have used the same device for at least 24 weeks prior to screening
- Willing to sign informed consent and comply with study procedures
You will not qualify if you...
- History of surgery on the target knee within 24 weeks before screening
- History of arthroscopic treatment on the target knee within 24 weeks before screening
- Need for surgical intervention on the target knee at screening
- Ligament instability grade II or higher in target knee at screening
- Orthopedic conditions like fractures or deformities affecting the target knee
- Pain in the target knee due to other joint conditions or osteoarthritis elsewhere
- Comorbidities including rheumatoid arthritis, gout, severe organ diseases, recent cancer, or coagulation disorders
- Infection or inflammation in the target knee joint
- Severe effusion or local skin disorders at the target knee
- Hypersensitivity to porcine products or components of the investigational device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration with evaluations up to 24 weeks
Participants receive an intra-articular injection of the investigational device ALLOHEAL or an active comparator to treat knee osteoarthritis.
1 baseline visit and 4 follow-up visits at 6, 10, 16, and 24 weeks
Trial Site Locations
Total: 1 location
1
Seok Jung Kim
Uijeongbu-si, South Korea
Actively Recruiting
Research Team
K
Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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