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

Medipost

Status and phase: Active, not recruiting; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Biological: SMUP-IA-01(mid-dose); Drug: High Hyal Plus; Biological: SMUP-IA-01(low-dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06798727

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups

SMUP-IA-01(low-dose)

Experimental group

Description:

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)

Treatment:

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

SMUP-IA-01(mid-dose)

Experimental group

Description:

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)

Treatment:

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

High Hyal Plus Inj.

Active Comparator group

Description:

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

Treatment:

Drug: High Hyal Plus