Knee OsteoarthritisALH-CT-01NCT07513415
A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis
A study testing ALLOHEAL and Conjuran in people with Knee Osteoarthritis, run by Endovision Co., Ltd. at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ALLOHEAL and Conjuran
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seok Jung Kim
Uijeongbu-si
Seok jung kim, Professor, +82 10 8783 7996, peter@catholic.ac.kr
About this study
Official title: 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
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.
Read the 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
- Being tested
- ALLOHEAL, Conjuran
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLOHEALDevice
ALLOHEAL is an intra-articular injectable filler administered to patients with knee osteoarthritis to improve joint function and reduce pain.
ConjuranDevice
An active comparator administered via intra-articular injection for the treatment of knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| ALLOHEAL Group | Experimental | Not described Receives: Device: ALLOHEAL |
| Comparator Group | Active comparator | Not described Receives: Device: Conjuran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain measured by Visual Analog Scale (VAS)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start4 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endovision Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Uijeongbu St. Mary's Hospital, National Health Insurance Service Ilsan Hospital, The Catholic University of Korea, Seoul National University Hospital, Chung-Ang University Gwangmyeong Hospital, Ajou University School of Medicine, Konkuk University Medical Center, Bundang CHA General Hospital, Yonsei University Health System, Severance Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513415
- Sponsor's protocol ID
- UC4DDDV0093
- Other IDs
- PRE20260108-005
- Acronym
- ALH-CT-01
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07513415
- Acronym / sponsor ID
- ALH-CT-01 / UC4DDDV0093
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Endovision Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Uijeongbu St. Mary's Hospital, National Health Insurance Service Ilsan Hospital, The Catholic University of Korea, Seoul National University Hospital, Chung-Ang University Gwangmyeong Hospital, Ajou University School of Medicine, Konkuk University Medical Center, Bundang CHA General Hospital, Yonsei University Health System, Severance Hospital
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLOHEAL Group | Experimental | Device: ALLOHEAL |
| Comparator Group | Active comparator | Device: Conjuran |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLOHEALALLOHEAL is an intra-articular injectable filler administered to patients with knee osteoarthritis to improve joint function and reduce pain. | Device | ALLOHEAL Group |
| ConjuranAn active comparator administered via intra-articular injection for the treatment of knee osteoarthritis. | Device | Comparator Group |
Primary outcome
Change in knee pain measured by Visual Analog Scale (VAS)
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALLOHEAL and Conjuran in people with Knee Osteoarthritis, run by Endovision Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim (+82 10 9026 4802, daye@endovision.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain measured by Visual Analog Scale (VAS) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.