NCT06798727

Brief 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 II trial (NCT05182034) will be followed-up until 60 months.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2 knee-osteoarthritis

Timeline
19mo left

Started Mar 2023

Longer than P75 for phase_2 knee-osteoarthritis

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2023Nov 2027

Study Start

First participant enrolled

March 20, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

4 years

First QC Date

January 23, 2025

Last Update Submit

February 4, 2025

Conditions

Knee Osteoarthritis

Keywords

human umbilical cord blood derived mesenchymal stem cellshUC-MSCsKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's baseline.

    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, 24 and 60 after treatment

  • +2 more secondary outcomes

Study Arms (3)

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)

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)

Biological: SMUP-IA-01(mid-dose)

High Hyal Plus Inj.

ACTIVE COMPARATOR

A single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml)

Drug: High Hyal Plus

Interventions

SMUP-IA-01(low-dose)BIOLOGICAL

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

Also known as: Human umbilical cord blood-derived mesenchymal stem cells
SMUP-IA-01(low-dose)
SMUP-IA-01(mid-dose)BIOLOGICAL

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

Also known as: Human umbilical cord blood-derived mesenchymal stem cells
SMUP-IA-01(mid-dose)
High Hyal PlusDRUG

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

High Hyal Plus Inj.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Seoul Nation University Bundang Hospital

Gyeonggi-do, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospita

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase 2's long term follow-up Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 29, 2025

Study Start

March 20, 2023

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

February 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)