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

NCT ID: NCT06798727

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Phase 2's long term follow-up Study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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)

Group Type EXPERIMENTAL

SMUP-IA-01(low-dose)

Intervention Type BIOLOGICAL

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

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)

Group Type EXPERIMENTAL

SMUP-IA-01(mid-dose)

Intervention Type BIOLOGICAL

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

High Hyal Plus Inj.

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

Group Type ACTIVE_COMPARATOR

High Hyal Plus

Intervention Type DRUG

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

Interventions

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SMUP-IA-01(low-dose)

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

Intervention Type BIOLOGICAL

SMUP-IA-01(mid-dose)

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

Intervention Type BIOLOGICAL

High Hyal Plus

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

Intervention Type DRUG

Other Intervention Names

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Human umbilical cord blood-derived mesenchymal stem cells Human umbilical cord blood-derived mesenchymal stem cells

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipost Co Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul Nation University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospita

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MP-SMUP-IA-01-P02-F/U

Identifier Type: -

Identifier Source: org_study_id

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