Knee OsteoarthritisPhase 1NCT04037345
Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
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 clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K\&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. 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
- 7 Oct 2019to 12 Nov 2020
- 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
- Male and female over 19 years of age
- Subject with knee osteoarthritis (OA) and were diagnosed K\&L grade 2 or 3 in radioactive examination at time of screening
- Subject with more than 40mm joint pain on the 100-mm VAS, at the time of screening
- Subject who were diagnosed as knee osteoarthritis by American College of Rheumatology (ACR) guideline criteria, at the time of screening
- Subject with Body mass index (BMI) ≤35 kg/m2 at the time of screening
- Subject with ligament instability ≤Grade II (grade o: no ligament instability, grade I: 0 ~ 5㎜, grade Ⅱ: 5 ~ 10 ㎜, grade Ⅲ: > 10 ㎜) at the time of screening
- Subject who agree to maintain contraception during study period
- Subject who voluntarily agreed to participate in the study, and signed informed consent
Who cannot join
- Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90mmHg even with treatment with more than three(3) antihypertensive drugs
- Subject with serious medical conditions other than cardiovascular disease
- Subject with, or with a medical history of auto-immune diseases
- Subject with an infection that requires parenteral antibiotic administration.
- Subject with a medical history of mental disorder or epilepsy
- Subject with chronic inflammatory joint diseases such as rheumatoid arthritis (e.g., osteoarthritis with infectious joint disease, gouty arthritis, and osteoarthritis)
Show all 18Show fewer
- Subject who had surgery or radiation therapy on knee joint area, or have not recovered from side effects of knee joint surgery within 12 weeks before screening
- Subject who are pregnant or lactating
- Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
- Subject who were diagnosed with cancer within 5 years before screening
- Subject who particiapted in another clinical trial within 4 weeks before screening of this clinical trial
- Subject who were administered with immunosuppressnats such as cyclosporin A or azathioprine within 6 weeks before screening
- Subject who had intra-articular administration such as sodium hyaluronate injections within 6 month before screening
- Subject who are suffering from skin disease or considered inappropriate for injection in the injection site
- Subject who has history of allergic response to hyaluronate injections or DMSO (cryopreservative) or Gentamicin (antibiotics)
- Subject who are consiered inappropriate for MRI assessment with Tesla higher than 3.0
- Subject with medical history of cell therapy product administration or are scheduled to administer other cell therapy product
- Subject who principal investigator (PI) considers inappropriate to participate in the study due to any reasons other than those listed above
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: A Open, Single-center, Phase 1 Trial to Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
This clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K\&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. Investigator selected knee to be evaluated (right or left) and administered investigational product to selected knee on Day 1.
A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).
Read the detailed description
All subjects in each dose-group will visit 1 month* (visit 5, 1 month±5 days) after administration of investigational product to evaluate dose limit toxicity (DLT) and determine whether to drop or proceed to next dose level.
Total 5 visit (1week, 1 month, 2 months, 3 months, 6 months) until 6 months after administration of investigational product is planned to assess safety through vial sign, laboratory tests, and exploratory efficacy of IP will be assessed through Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS) and International Knee Documentation Committee (IKDC) subjective knee evaluation.
- 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
Also called Human umbilical cord blood-derived mesenchymal stem cells
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 Osteoarthritis Index) compared to baseline at 6 months after treatment
Change of total scorein WOMAC compared to baseline at 6 months after treatment. WOMAC consists of three subscales: pain, stiffness, and physical function, and is performed on baseline (visit 2) and final (Visit 8) visits. Total of 24 questions are evaluated with 5 questions for pain, 2 questions for stiffness, and 17 questions for physical function. Each question is scored between 0 point (no symptom) ~ 4 points (severe symptoms) scale, and the total score is between 0 point (no symptoms) ~ 96 points (higher score representing worse symptoms).
Measured: Baseline, Month 6
Secondary outcomes (7)
Change of score in WOMAC three subscales (Pain, stiffness, physical function)compared to baseline at 6 months after treatment
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: Baseline, Month 6
Change of score in 100 mm VAS (Visual Analogue Scale) compared to baseline
The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
Measured: Baseline, Month 1, Month 2, Month 3, Month 6
Change of score in IKDC(International Knee Documentation Committee)compared to baseline
Change of score in IKDC compared to baseline. IKDC subjective knee evaluation consists of three categories: symptoms, sports activities, and functions. For each category, there are 7 questions for symptoms, 2 questions for sports activities, and 2 questions for functions, a total of 11 questions for evaluation. 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: Baseline, Month 1, Month 2, Month 3, Month 6
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score) compared to baseline at 6 months after treatment
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: Baseline, Month 6
Change in K&L(Kellgren-Lawrence) grade compared to the baseline at 3 months and 6 months after treatment
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: Baseline, Month 3, Month 6
Change in joint space width compared to the baseline at 3 months and 6 months after treatment
Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography
Measured: Baseline, Month 3, Month 6
Change in mechanical axis, anatomical axis compared to the baseline at 3 months and 6 months after treatment
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 middaphyseal line of the femur and tibia.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start7 Oct 2019
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
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 (actual)
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
- NCT04037345
- Sponsor's protocol ID
- MP-SMUP-IA-01-P01
- Status last verified
- Aug 2020
- First submitted
- 17 Jul 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open, Single-center, Phase 1 Trial to Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04037345
- Acronym / sponsor ID
- MP-SMUP-IA-01-P01
- Conditions
- Knee Osteoarthritis
- Keywords
- human umbilical cord blood derived mesenchymal stem cells, Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 30 Jul 2019 (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 clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K\&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. Investigator selected knee to be evaluated (right or left) and administered investigational product to selected knee on Day 1.
A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).
Detailed description
All subjects in each dose-group will visit 1 month* (visit 5, 1 month±5 days) after administration of investigational product to evaluate dose limit toxicity (DLT) and determine whether to drop or proceed to next dose level.
Total 5 visit (1week, 1 month, 2 months, 3 months, 6 months) until 6 months after administration of investigational product is planned to assess safety through vial sign, laboratory tests, and exploratory efficacy of IP will be assessed through Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS) and International Knee Documentation Committee (IKDC) subjective knee evaluation.
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 (8 listed)
- Male and female over 19 years of age
- Subject with knee osteoarthritis (OA) and were diagnosed K\&L grade 2 or 3 in radioactive examination at time of screening
- Subject with more than 40mm joint pain on the 100-mm VAS, at the time of screening
- Subject who were diagnosed as knee osteoarthritis by American College of Rheumatology (ACR) guideline criteria, at the time of screening
- Subject with Body mass index (BMI) ≤35 kg/m2 at the time of screening
Key exclusion criteria (18 listed)
- Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90mmHg even with treatment with more than three(3) antihypertensive drugs
- Subject with serious medical conditions other than cardiovascular disease
- Subject with, or with a medical history of auto-immune diseases
- Subject with an infection that requires parenteral antibiotic administration.
- Subject with a medical history of mental disorder or epilepsy
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)Also: Human umbilical cord blood-derived mesenchymal stem cellsA 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 Osteoarthritis Index) compared to baseline at 6 months after treatment
Time frame: Baseline, Month 6
Change of total scorein WOMAC compared to baseline at 6 months after treatment. WOMAC consists of three subscales: pain, stiffness, and physical function, and is performed on baseline (visit 2) and final (Visit 8) visits. Total of 24 questions are evaluated with 5 questions for pain, 2 questions for stiffness, and 17 questions for physical function. Each question is scored between 0 point (no symptom) ~ 4 points (severe symptoms) scale, and the total score is between 0 point (no symptoms) ~ 96 points (higher score representing worse symptoms).
7 secondary outcomes
Change of score in WOMAC three subscales (Pain, stiffness, physical function)compared to baseline at 6 months after treatment
Time frame: Baseline, Month 6
Change of score in 100 mm VAS (Visual Analogue Scale) compared to baseline
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6
Change of score in IKDC(International Knee Documentation Committee)compared to baseline
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score) compared to baseline at 6 months after treatment
Time frame: Baseline, Month 6
Change in K&L(Kellgren-Lawrence) grade compared to the baseline at 3 months and 6 months after treatment
Time frame: Baseline, Month 3, Month 6
Change in joint space width compared to the baseline at 3 months and 6 months after treatment
Time frame: Baseline, Month 3, Month 6
Change in mechanical axis, anatomical axis compared to the baseline at 3 months and 6 months after treatment
Time frame: Baseline, Month 3, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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 8 inclusion and 18 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: finished, as of the sponsor's last update on 24 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Osteoarthritis Index) compared to baseline at 6 months after treatment (time frame: Baseline, Month 6). 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 24 Feb 2021.