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NCT Number: NCT06798727

Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul Nation University Bundang Hospital, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

SMUP-IA-01(low-dose)

Biological

A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)

Other names: Human umbilical cord blood-derived mesenchymal stem cells

SMUP-IA-01(mid-dose)

Biological

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

Other names: Human umbilical cord blood-derived mesenchymal stem cells

High Hyal Plus

Drug

A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml)

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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).

  2. Change of score in 100 mm VAS (Visual Analogue Scale)

    Time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment

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

  3. Change of score in IKDC(International Knee Documentation Committee)

    Time frame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment

    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.

  4. Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)

    Time frame: Time Frame: Month 12 and 24 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

  5. Change in K&L(Kellgren-Lawrence) grade

    Time frame: Time Frame: Month 12, 24 and 60 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

  6. Change in joint space width

    Time frame: Time Frame: Month 12, 24 and 60 after treatment

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

  7. Change in mechanical axis, anatomical axis

    Time frame: Time Frame: Month 12, 24 and 60 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 middiaphyseal line of the femur and tibia

Sponsors and collaborators

Lead sponsor

Medipost Co Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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