Osteoarthritis, KneePhase 1NCT06539429
Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L
A Phase 1 study testing ANT-301 in people with Osteoarthritis, Knee, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ANT-301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2024to 15 May 2026
- Phase
- Phase 1
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
- Patients aged 19 to 70 years old.
- Patients diagnosed with K\&L grade III/IV knee osteoarthritis
- Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale
Who cannot join
- Patients with joint diseases other than osteoarthritis
- Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
- Patients who received intra-articular injections within 6 months prior to the screening
- Patients who have received systemic steroid therapy within 3 months prior to the screening
- Patients who have received immunosuppressive agents within 3 months prior to the screening
- Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
- Patients who are unwilling to use contraception during the clinical trial period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.
Read the detailed description
Study Design: open-label, single-center, dose-escalation study
- Conditions
- Osteoarthritis, Knee
- Being tested
- ANT-301
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-301Biological
Administration on Day 1
| Study group | Role | What they receive |
|---|---|---|
| ANT-301 | Experimental | Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel Receives: Biological: ANT-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Number of Adverse events and Laboratory Abnormalities
Measured: Week 2, 4, 8, 12, 24 and Month 12
Secondary outcomes (3)
Pain improvement according to VAS scale measurements
The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.
Measured: Baseine, Week 4, 8, 12, 24 and Month 12
IKDC score
IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: Baseline, Week 4, 8, 12, 24 and 12 months
WOMAC questionnaire score
Difference in WOMAC questionnaire scores between baseline and each visit
Measured: Baseline, Week 4, 8, 12, 24 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start22 Oct 2024
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539429
- Sponsor's protocol ID
- ANT-301-102
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT06539429
- Acronym / sponsor ID
- ANT-301-102
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 6 Aug 2024 (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.
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.
Detailed description
Study Design: open-label, single-center, dose-escalation study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANT-301 | Experimental | Biological: ANT-301Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
- Patients aged 19 to 70 years old.
- Patients diagnosed with K\&L grade III/IV knee osteoarthritis
- Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale
Key exclusion criteria (7 listed)
- Patients with joint diseases other than osteoarthritis
- Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
- Patients who received intra-articular injections within 6 months prior to the screening
- Patients who have received systemic steroid therapy within 3 months prior to the screening
- Patients who have received immunosuppressive agents within 3 months prior to the screening
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 |
|---|---|---|
| ANT-301Administration on Day 1 | Biological | ANT-301 |
Primary outcome
Safety assessment
Time frame: Week 2, 4, 8, 12, 24 and Month 12
Number of Adverse events and Laboratory Abnormalities
3 secondary outcomes
Pain improvement according to VAS scale measurements
Time frame: Baseine, Week 4, 8, 12, 24 and Month 12
IKDC score
Time frame: Baseline, Week 4, 8, 12, 24 and 12 months
WOMAC questionnaire score
Time frame: Baseline, Week 4, 8, 12, 24 and 12 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 22 Sep 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANT-301 in people with Osteoarthritis, Knee, run by Anterogen 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (time frame: Week 2, 4, 8, 12, 24 and Month 12). 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 22 Sep 2025.