NCT07513415

A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis

A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Pivotal Clinical Study to Evaluate the Safety and Efficacy of Intra-articular Filler 'ALLOHEAL' in Knee Osteoarthritis Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Endovision Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

ENDOVISION Co., Ltd. has developed an intra-articular knee injection with sodium polynucleotide, chitosan, and type I collagen as its main components, and aims to demonstrate the non-inferiority of the investigational device, ALLOHEAL, compared with the control device, Conjuran®, when administered intra-articularly to patients with knee osteoarthritis for the purpose of reducing mechanical friction within the joint cavity.

Detailed description

In this clinical trial, based on clinical literature on PN, which is the main component of the investigational device ALLOHEAL, the VAS assessment at Week 16 was set as the primary efficacy endpoint. As the investigational device contains chitosan and collagen in addition to PN, the follow-up period was set to 24 weeks based on the aforementioned literature in order to obtain additional safety data for these two components. Efficacy and safety will be evaluated at 6, 10, 16, and 24 weeks after the initial application of the investigational medical device.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ALLOHEAL	ALLOHEAL is an intra-articular injectable filler administered to patients with knee osteoarthritis to improve joint function and reduce pain.
DEVICE	Conjuran	An active comparator administered via intra-articular injection for the treatment of knee osteoarthritis.

Timeline

• Start date: 2025-02-04
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: South Korea