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Knee OsteoarthritisPhase 2NCT05182034

Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

A Phase 2 study testing SMUP-IA-01(low dose) and SMUP-IA-01(mid dose) in people with Knee Osteoarthritis, run by Medipost Co Ltd. at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial is for patients who have been diagnosed with Kellgren-Lawrence (K\&L) Grade 2 or 3 knee osteoarthritis on radiographic examination. Only subjects who voluntarily agree to participate by filling out the written Informed Consent document will undergo screening for subject selection… 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) and SMUP-IA-01(mid dose)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
5 sitesSouth Korea
Study dates
24 Feb 2022to 17 Oct 2023
Phase
Phase 2
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

  • Patients who are ≥ 19 years of age on the date on which the consent form was signed
  • Patients diagnosed with knee osteoarthritis in at least one knee according to the clinical and radiological definition criteria of American College of Rheumatology (ACR) guidline at screening visit
  • Patients with knee OA corresponding to K\&L Grade 2 or 3 on radiographic examination at screening visit
  • Patients with less than 35 of BMI at screening visit
  • Patients who voluntarily decide to participate and sign the consent form
  • Patients who have persistent symptoms despite having undergone a reasonable trial of standard therapy (i.e., for a minimum of 3 months)

Who cannot join

  • Patients with any of the following diseases.
  • infectious arthritis, autoimmune or inflammatory joint diseases, gout, recurrent pseudogout, Paget's disease, intra-articular displaced fracture, ochronosis, acromegaly, haemochromatosis, Wilson's disease, genetic disease (hyperkinesia etc.), genetic collagen disorder, etc.
  • Patients who have ever undergone surgery or radiotherapy in the knee joint area within the 12 weeks prior to the screening visit date, or who have not been recovered from its side effect yet.
  • Patients with SIF (Subchondral insufficiency fracture) corresponding to type II of the RPOA (rapidly progressive osteoarthritis).
  • Patients whose physical examination results show severe degree of ligament instability.
  • Patients who have ever been given any intraarticular drug injection (i.e., hyaluronic acid injection, etc.) in to-be-treated (index) knee within the 6 months, prior to the screening visit date.
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  • Patients who have ever been given steroids via intraarticular injection in to-be-treated (index) knee within the 12 weeks prior to the screening visit date.
  • Patients who have ever taken medications or given therapy below within the past 2 weeks on the basis of screening visit date. However, if patients have 14 days of wash-out period, the patient is allowed to participate.
  • drugs containing the ingredient of glucosamine, chondroitin sulfate, or diacerein
  • drugs containing herbal ingredient or herbal drugs for knee OA pain relief
  • anti-inflammatory analgesics or NSAIDs (prescription/non-prescription drugs). (However, patients who take acetaminophen and have 3 days of wash-out period are allowed to participate.)
  • oral steroids
  • hospital physiotherpy or oriental medicine treatment (buhang, acupunture, moxibustion etc.)
  • Patients who have skin disease on injection site or who are judged inappropriate for intra-articular injection on to-be-treated knee.
  • Patients who are judged unsuitable for MRI scanning (3.0 Tesla or higher) due to an insertion of metal material (i.e., heart pacemaker, cerebral aneurysm clip, etc.) or obstructive phobia. However, patients who have an insertion of metal material that is not affected by the magnetic field is allowed to participate
  • Patients with clinically significant past or present illness as follows;
  • heart diseases (i.e., myocardial infarction, coronary artery bypass surgery, arrhythmia and other serious heart diseases, etc.)
  • uncontrolled hypertension (not controlled down to 140/90 mmHg or below even after treatment with 3 or more antihypertensive drugs)
  • kidney disease (i.e., chronic kidney failure, glomerulonephritis, etc.)
  • liver disease (i.e., acute or chronic liver disease such as cirrhosis, fatty liver, etc.)
  • endocrine diseases (i.e., thyroiditis, diabetes insipidus, Cushing's disease, etc.)
  • other serious systemic diseases
  • Patient with ongoing autoimmune disorder that requires treatment with an immunosuppressive medication
  • Patients with infection that requires administration of parenteral antibiotics
  • Patients with a history of mental illness or epilepsy
  • Patients who have been diagnosed with cancer within the 5 years prior to the screening visit date
  • Patients who have been given immunosuppressive drugs such as cyclosporin A or azathioprine within the 6 weeks prior to the screening visit
  • Patients with a history of allergic reactions to hyaluronic acid injections, cryoprotectant (dimethyl sulfoxide, DMSO), or gentamicin.
  • Patients who are pregnant or lactating, or patients who have a plan to become pregnant during the study period
  • Male or female patients who do not agree to avoid pregnancy or the use of appropriate contraceptive methods during the study period. But women who have given infertility surgery or who have passed menopause one year or more are allowed to participate without the consent for contraception.
  • Patients who have been given any other cell therapy products or who plan to do so during the study period.
  • Patients who have been given any other investigational products including device within the 3 months prior to the screening visit date.
  • Patients who are judged by the investigator as inappropriate for enrollment into the study, for any reasons other than the reasons specified above.

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

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-Blinded, Active-Controlled, Phase II Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

This clinical trial is for patients who have been diagnosed with Kellgren-Lawrence (K\&L) Grade 2 or 3 knee osteoarthritis on radiographic examination. Only subjects who voluntarily agree to participate by filling out the written Informed Consent document will undergo screening for subject selection (inclusion/exclusion) criteria, at which time the severity of OA in each knee will be used to determined which knee will be treated (index knee - i.e., the more severely affected knee), and enroll in this study.

Read the detailed description

Patients who meet the inclusion/exclusion criteria will be randomly assigned at visit 2 to either of study group 1(low-dose), study group 2 (mid-dose) or active control group at 1:1:1 ratio. Patients will be administered with investigational product. Investigational product will be administered into the to-be-treated (index) knee one time within 7 days after randomization.

All patients enrolled will be followed up a total of 6 times (1, 4, 8, 12, 24, and 52 weeks) for up to post-dose 12 months. The patients should visit the study facility according to the visit schedule, and will undergo safety evaluation (vital sign, laboratory test, etc.) and efficacy evaluation [Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS), International Knee Documentation Committee (IKDC) subjective knee evaluation].

Being tested
SMUP-IA-01(low dose), SMUP-IA-01(mid dose), Active Control Group Sodium chloride
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 SMUP allogenic cord blood-derived mesenchymal stem cell (SMUP-Cell)

    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 SMUP allogenic cord blood-derived mesenchymal stem cell (SMUP-Cell)

    A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)

  • Active Control Group Sodium chlorideDrug

    Also called Sodium chloride

    A single knee administration of Sodium chloride

Study groups in NCT05182034
Study groupRoleWhat they receive
Study Group 1: SMUP-IA-01 (low dose)ExperimentalInvestigational Product - 4.0×10^6 cells/2 mL of SMUP-IA-01 (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
Receives: Biological: SMUP-IA-01(low dose)
Study Group 2:SMUP-IA-01 (mid dose)ExperimentalInvestigational Product - 1.0×10^7 cells/2 mL of SMUP-IA-01 (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
Receives: Biological: SMUP-IA-01(mid dose)
Active Control GroupActive comparatorInvestigational Product - 2 ml of 1% sodium hyaluronate (2 ml of sodium chloride injection is administered before administration of 1% sodium hyaluronate)
Receives: Drug: Active Control Group Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score at post-dose 52 weeks from baseline

    Total score is between 0 point (no symptoms) ~ 96 points (higher score representing worse symptoms).

    Measured: Baseline, 52 week

Secondary outcomes (9)

  1. Change amount of WOMAC total score at post-dose 24 weeks from the baseline

    Total score is between 0 point (no symptoms) ~ 96 points (higher score representing worse symptoms).

    Measured: Baseline, 24 week

  2. Chage amount of WOMAC score by item (pain, stiffness, physical function) at post-dose 24 weeks and 52 weeks from the 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: Baseline, 24 week, 52 week

  3. Chage amount of 100-mm VAS((Visual Analogue Scale) at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks from the baseline

    The score ranges from "0" or no pain to "100" very severe pain

    Measured: Baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52 week

  4. Chage amount of IKDC(International Knee Documentation Committee) at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks from the 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, 1 week, 4 week, 8 week, 12 week, 24 week, 52 week

  5. Change in the WOMAS(whole-organ magnetic resonance imaging score) at post-dose 52 weeks from the baseline

    Total score is between 0 point (no symptoms) ~ 96 points (higher score representing worse symptoms).

    Measured: Baseline, 52 week

  6. Change in T2 mapping at post-dose 52 weeks from the baseline

    Changes on the knee structure through qualitative and quantitative evaluation of the collagen matrix of knee cartilage.

    Measured: Baseline, 52 week

  7. Change in K&L grade, joint space width, mechanical axis, and anatomical axis at post-dose 52 weeks from the baseline

    K \& L grade (0 to 4 Grade): which means that the higher the grade, the greater the joint damage and the stenosis of the joint.

    Joint space width(mm): Evaluation of disease progression in target knee as ascertained by change from baseline joint space width (JSW) determined using radiography.

    Mechanical axis(Angle): A line connecting the femoral head center point and the ankle joint center point. Anatomical axis(Angle): The middiaphyseal line of the femur and tibia

    Measured: Baseline, 52 week

  8. Change amount of biomarkers at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks against the baseline; serum CTX-I, Serum HA, Serum MMP-3, Urine CTX-I, Urine CTX-II.

    serum C-terminal cross-linking telopetides of collagen type I(CTX-I), serum hyaluronan, serum matrix metalloproteinase-3 (MMP-3), urine C-terminal cross-linking telopetides of collagen type II (CTX -II), urine C-terminal cross-linking telopetides of collagen type I(CTX-I).

    Serum CTX-I, Serum HA, Serum MMP-3, Urine CTX-I, Urine CTX-II are reported in pg/ml.

    Measured: baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52week

  9. Percentage of patients who took the rescue drugs and dosage at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks

    Subjects will receive Patient Diary, and use of the rescue drug should be recorded on the Patient Diary.

    Measured: 1 week, 4 week, 8 week, 12 week, 24 week, 52week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start24 Feb 2022
  3. Primary completion17 Oct 2023
  4. Study completion17 Oct 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182034
Sponsor's protocol ID
MP-SMUP-IA-01-P02
Status last verified
Feb 2025
First submitted
12 Dec 2021
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SMUP-IA-01(low dose) and SMUP-IA-01(mid dose) 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 6 inclusion and 33 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 5 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?

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 in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score at post-dose 52 weeks from baseline (time frame: Baseline, 52 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182034.

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 5 Feb 2025.

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