Comparing the knee injectable filler ALLOHEAL with Conjuran for osteoarthritis pain

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

This test sees if the injectable filler ALLOHEAL reduces knee pain as well as Conjuran in people aged 40–79 with knee osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 286 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Endovision Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Uijeongbu-si)
• Trial ID: NCT07513415 on ClinicalTrials.gov

What this trial studies

This interventional non-inferiority trial compares intra-articular ALLOHEAL (sodium polynucleotide with chitosan and type I collagen) to the control device Conjuran® in patients with knee osteoarthritis. The primary efficacy endpoint is change in weight-bearing Visual Analogue Scale (VAS) pain at Week 16, with additional safety and efficacy assessments at Weeks 6, 10, 16, and 24. Eligible participants have Kellgren-Lawrence grade I–III disease and a baseline weight-bearing VAS ≥40 mm and receive the assigned intra-articular injection with follow-up through 24 weeks. The design aims to show ALLOHEAL is not inferior to Conjuran while collecting extra safety data on the chitosan and collagen components.

Who should consider this trial

Good fit: Adults aged 40–79 with knee osteoarthritis (Kellgren-Lawrence grade I–III) who have had at least 8 weeks of knee pain and a weight-bearing VAS score of ≥40 mm are the intended candidates.

Not a fit: Patients with very advanced osteoarthritis (Kellgren-Lawrence grade IV), inflammatory arthritis, recent knee surgery, or known allergy to the product components are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, ALLOHEAL could provide a similarly effective injectable option to reduce knee pain and joint friction with an acceptable safety profile.

How similar studies have performed: Prior studies of intra-articular sodium polynucleotide have shown symptomatic pain relief, but the specific combination of polynucleotide with chitosan and type I collagen in ALLOHEAL has been less studied and needs additional safety data.

Eligibility criteria

Inclusion Criteria:

* 1)Men and women aged ≥40 and \<80 years at the date of signing the written informed consent.

  2)Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) guidelines within 24 weeks prior to the screening visit or at the screening visit.

  3)Experiencing pain in the osteoarthritic knee for at least 8 weeks. 4)At the screening visit, having a Kellgren-Lawrence grade I-III severity in the knee joint selected for evaluation based on X-ray findings (if both knees are symptomatic and show the same weight-bearing VAS score, the knee with the higher Kellgren-Lawrence grade will be selected as the target knee; the target knee cannot be changed during the clinical trial).

  5)At the screening visit, having a weight-bearing VAS (Visual Analogue Scale) score of at least 40 mm in at least one knee joint (if both knees are symptomatic, the knee with the higher weight-bearing VAS score will be selected as the target knee; the target knee cannot be changed during the clinical trial).

  6)At the screening visit, having a Body Mass Index (BMI) of less than 35 kg/m². 7)Able to walk without assistive devices such as a walker or cane (however, if the subject has been clinically using an assistive device for ≥24 weeks prior to the screening visit, assessment can be conducted including the device, and the same device must continue to be used until the completion of the trial).

  8)Willing to voluntarily sign the written informed consent form. 9)Capable of understanding and complying with the procedures and visit schedule of the clinical trial.

Exclusion Criteria:

* 1)History of surgical procedures (including meniscectomy or arthroscopic surgery) on the target knee within 24 weeks prior to the screening visit. (However, if the subject has a history of joint surgery on the contralateral knee, hip, or other joints that is unlikely to affect the clinical assessment of the target knee, participation in this clinical trial is allowed.) 2)History of arthroscopic treatment on the target knee within 24 weeks prior to the screening visit.

  3)Requiring surgical intervention for the target knee at the screening visit. 4)Having ligament instability of grade II or higher in the target knee on physical examination at the screening visit (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: \>10 mm).

  5)Presence of orthopedic conditions such as fractures or joint deformities in the target knee that may affect or interfere with treatment efficacy (joint deformity refers to varus or valgus deformity ≥10° in the knee joint).

  6)Experiencing pain in the target knee due to surrounding joint structures or coexisting osteoarthritis in other areas (e.g., hip) that may influence assessment of knee pain.

  7)Presence of the following comorbidities: Rheumatoid arthritis, spondyloarthritis, connective tissue disease, polymyalgia rheumatica, gout, Paget's disease, septic arthritis, psoriatic arthritis, joint fractures, osteonecrosis, fibromyalgia, chondrocalcinosis
* Amyloidosis
* Severe hepatic, cardiac, or renal disease
* Malignant tumors within the past 5 years
* Coagulation disorders such as hemophilia 8) Infection or inflammation in the target knee joint. 9) Severe effusion in the target knee joint. 10) Local skin disorders at the target knee. 11)Hypersensitivity to porcine-derived products. 12)Hypersensitivity or history of adverse reactions to the main or other components of the investigational medical device used in this clinical trial.

Where this trial is running

Uijeongbu-si

• Seok Jung Kim — Uijeongbu-si, South Korea (Recruiting)

Study contacts

• Study coordinator: Kim

Conditions Knee Osteoarthritis