Knee OsteoarthritisPhase 2NCT06798727
Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
A Phase 2 study testing SMUP-IA-01(low-dose), SMUP-IA-01(mid-dose) and High Hyal Plus in people with Knee Osteoarthritis, run by Medipost Co Ltd. at 5 sites in South Korea.
Trial summary
This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase II trial (NCT05182034) will be followed-up until 60 months. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SMUP-IA-01(low-dose), SMUP-IA-01(mid-dose) and High Hyal Plus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 20 Mar 2023to 30 Nov 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase II clinical trial.
- Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Who cannot join
- Subject who were not enrolled in phase II clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
- Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul Nation University Bundang Hospital
Gyeonggi-do
Gangnam Severance Hospital
Seoul
Korea University Anam Hospita
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
About this study
This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase II trial (NCT05182034) will be followed-up until 60 months.
Read the detailed description
The subjects will be followed up at 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
- Conditions
- Knee Osteoarthritis
- Being tested
- SMUP-IA-01(low-dose), SMUP-IA-01(mid-dose), High Hyal Plus
- Keywords
- human umbilical cord blood derived mesenchymal stem cells, hUC-MSCs, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMUP-IA-01(low-dose)Biological
Also called Human umbilical cord blood-derived mesenchymal stem cells
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)
SMUP-IA-01(mid-dose)Biological
Also called Human umbilical cord blood-derived mesenchymal stem cells
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)
High Hyal PlusDrug
A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml)
| Study group | Role | What they receive |
|---|---|---|
| SMUP-IA-01(low-dose) | Experimental | A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) Receives: Biological: SMUP-IA-01(low-dose) |
| SMUP-IA-01(mid-dose) | Experimental | A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) Receives: Biological: SMUP-IA-01(mid-dose) |
| High Hyal Plus Inj. | Active comparator | A single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml) Receives: Drug: High Hyal Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total score in WOMAC (Western Ontario and McMaster University)
Comparing WOMAC total score changes with baseline scores of SMUP-IA-01 phase I trial and scores of f/u study at 12 months, 24 months, 36 months, 48 months and 60months after treatment (score range 0-96, higher score represent worse symptoms).
Measured: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Secondary outcomes (7)
Change of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's baseline.
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Measured: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in 100 mm VAS (Visual Analogue Scale)
The score ranges from "0" or no pain to "100" very severe pain
Measured: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in IKDC(International Knee Documentation Committee)
The scores for each category are summed up and divided into 87, which is the maximum score possible, and then is evaluated by converting it into a scale of 100 points. Higher score indicates better function and less symptoms for the knee.
Measured: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
For structural and tissue evaluation of knee, MRI image of detailed knee parts are graded from min. 0 to max. 6. Lower number indicate normal status
Measured: Time Frame: Month 12 and 24 after treatment
Change in K&L(Kellgren-Lawrence) grade
The K \& L grade is 0 to 4 Grade, which means that the higher the grade, the greater the joint damage and the stenosis of the joint
Measured: Time Frame: Month 12, 24 and 60 after treatment
Change in joint space width
Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography
Measured: Time Frame: Month 12, 24 and 60 after treatment
Change in mechanical axis, anatomical axis
The degree of deformation of the lower half of the body is measured by measuring the angles of the mechanical axis and the anatomical axis with respect to the vertical axis. Mechanical axis: A line connecting the femoral head center point and the ankle joint center point. Anatomical axis: The middiaphyseal line of the femur and tibia
Measured: Time Frame: Month 12, 24 and 60 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start20 Mar 2023
- Primary completion20 Mar 2027 (estimated)
- Study completion30 Nov 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2's long term follow-up Study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798727
- Sponsor's protocol ID
- MP-SMUP-IA-01-P02-F/U
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 7 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
- ClinicalTrials.gov ID
- NCT06798727
- Acronym / sponsor ID
- MP-SMUP-IA-01-P02-F/U
- Conditions
- Knee Osteoarthritis
- Keywords
- human umbilical cord blood derived mesenchymal stem cells, hUC-MSCs, Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 29 Jan 2025 (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 follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase II trial (NCT05182034) will be followed-up until 60 months.
Detailed description
The subjects will be followed up at 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Phase 2's long term follow-up Study
| Arm | Type | Receives |
|---|---|---|
| SMUP-IA-01(low-dose) | Experimental | Biological: SMUP-IA-01(low-dose)A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) |
| SMUP-IA-01(mid-dose) | Experimental | Biological: SMUP-IA-01(mid-dose)A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) |
| High Hyal Plus Inj. | Active comparator | Drug: High Hyal PlusA single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase II clinical trial.
- Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Key exclusion criteria (2 listed)
- Subject who were not enrolled in phase II clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
- Other subjects, excluding those listed above, who were deemed unsuitable by the PI
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 |
|---|---|---|
| SMUP-IA-01(low-dose)Also: Human umbilical cord blood-derived mesenchymal stem cellsA single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL) | Biological | SMUP-IA-01(low-dose) |
| SMUP-IA-01(mid-dose)Also: Human umbilical cord blood-derived mesenchymal stem cellsA single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL) | Biological | SMUP-IA-01(mid-dose) |
| High Hyal PlusA single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml) | Drug | High Hyal Plus Inj. |
Primary outcome
Change of total score in WOMAC (Western Ontario and McMaster University)
Time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Comparing WOMAC total score changes with baseline scores of SMUP-IA-01 phase I trial and scores of f/u study at 12 months, 24 months, 36 months, 48 months and 60months after treatment (score range 0-96, higher score represent worse symptoms).
7 secondary outcomes
Change of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's baseline.
Time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in 100 mm VAS (Visual Analogue Scale)
Time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in IKDC(International Knee Documentation Committee)
Time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
Time frame: Time Frame: Month 12 and 24 after treatment
Change in K&L(Kellgren-Lawrence) grade
Time frame: Time Frame: Month 12, 24 and 60 after treatment
Change in joint space width
Time frame: Time Frame: Month 12, 24 and 60 after treatment
Change in mechanical axis, anatomical axis
Time frame: Time Frame: Month 12, 24 and 60 after treatment
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 Feb 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMUP-IA-01(low-dose), SMUP-IA-01(mid-dose) and High Hyal Plus in people with Knee Osteoarthritis, run by Medipost Co Ltd. at 5 sites 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 2 inclusion and 2 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change of total score in WOMAC (Western Ontario and McMaster University) (time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment). 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 Feb 2025.