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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: SMUP-IA-01(low-dose); Biological: SMUP-IA-01(mid-dose); Drug: High Hyal Plus

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Seoul Nation University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase II clinical trial.
2. Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.

Exclusion Criteria:

1. Subject who were not enrolled in phase II clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
2. Other subjects, excluding those listed above, who were deemed unsuitable by the PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Biological: SMUP-IA-01(low-dose); 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
Experimental: 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)	Biological: SMUP-IA-01(mid-dose); 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
Active Comparator: High Hyal Plus Inj.; A single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml)	Drug: High Hyal Plus; A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Time Frame: Month 12, 24, 36, 48 and 60 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	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	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	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	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	Time Frame: Month 12, 24 and 60 after treatment

Collaborators and Investigators

• Sponsor: Medipost Co Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; human umbilical cord blood derived mesenchymal stem cells; hUC-MSCs
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MP-SMUP-IA-01-P02-F/U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No