Knee OsteoarthritisPhase 1NCT04339504
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
A Phase 1 study testing SMUP-IA-01(low-dose), SMUP-IA-01(mid-dose) and SMUP-IA-01(high-dose) in people with Knee Osteoarthritis, run by Medipost Co Ltd. at 1 site 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 I trial (NCT04037345 ) 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 SMUP-IA-01(high-dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2020to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 I clinical trial.
- Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
- Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Who cannot join
- Subjects who were not enrolled in phase 1 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
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
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 I trial (NCT04037345 ) will be followed-up until 60 months.
Read the detailed description
The subjects will be followed up at 6-month, 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), SMUP-IA-01(high-dose)
- Keywords
- human umbilical cord blood derived mesenchymal stem cells, 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)
SMUP-IA-01(high-dose)Biological
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/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) |
| SMUP-IA-01(high-dose) | Experimental | A single knee administration of SMUP-IA-01 (high-dose, 2.0 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(high-dose) |
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: Month 12, 24, 36, 48 and 60 after treatment
Secondary outcomes (9)
Change of score in WOMAC three subscales (Pain, stiffness, physical function)
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: 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: 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: 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: 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: Month 12 and 24 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: Month 12 and 24 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: Month 12 and 24 after treatment
Rate of surgery to treat application site after treatment of SMUP-IA-01
Rate of surgery to treat application site after treatment of SMUP-IA-01
Measured: Month 6, 12, 24, 36, 48 and 60 after treatment
Changes in biomarker
Comparing biomarker changes with baseline of SMUP-IA-01 phase I trial and scores of f/u study at 12 months after treatment. urine C-terminal cross-linking telopeptides of collagen type II (CTX II), serum cartilage oligomeric matrix protein (COMP), serum matrix metalloproteinase-3 (MMP-3)
Measured: Month 12 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start14 Apr 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myungchul LEE, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339504
- Sponsor's protocol ID
- MP-SMUP-IA-P01-F/U
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2020
- Last updated
- 15 Mar 2023
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
- ClinicalTrials.gov ID
- NCT04339504
- Acronym / sponsor ID
- MP-SMUP-IA-P01-F/U
- Conditions
- Knee Osteoarthritis
- Keywords
- human umbilical cord blood derived mesenchymal stem cells, Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2020 (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 I trial (NCT04037345 ) will be followed-up until 60 months.
Detailed description
The subjects will be followed up at 6-month, 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
- None (open label)
- Number of arms
- 3
| 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) |
| SMUP-IA-01(high-dose) | Experimental | Biological: SMUP-IA-01(high-dose)A single knee administration of SMUP-IA-01 (high-dose, 2.0 x 10^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
- Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
- Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Key exclusion criteria (2 listed)
- Subjects who were not enrolled in phase 1 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) |
| SMUP-IA-01(high-dose)A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/2mL) | Biological | SMUP-IA-01(high-dose) |
Primary outcome
Change of total score in WOMAC (Western Ontario and McMaster University)
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).
9 secondary outcomes
Change of score in WOMAC three subscales (Pain, stiffness, physical function)
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in 100 mm VAS (Visual Analogue Scale)
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in IKDC(International Knee Documentation Committee)
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
Time frame: Month 12 and 24 after treatment
Change in K&L(Kellgren-Lawrence) grade
Time frame: Month 12 and 24 after treatment
Change in joint space width
Time frame: Month 12 and 24 after treatment
Change in mechanical axis, anatomical axis
Time frame: Month 12 and 24 after treatment
Rate of surgery to treat application site after treatment of SMUP-IA-01
Time frame: Month 6, 12, 24, 36, 48 and 60 after treatment
Changes in biomarker
Time frame: Month 12 after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
Myungchul LEE, MD, PhD principal investigator
Seoul National University Hospital
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 SMUP-IA-01(low-dose), SMUP-IA-01(mid-dose) and SMUP-IA-01(high-dose) in people with Knee Osteoarthritis, run by Medipost 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 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunyoung LEE (82234656748, ley0113@medi-post.co.kr), or a site near the patient. 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: 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 15 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.