Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial

Medipost

Status and phase: Enrolling; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Biological: SMUP-IA-01(low-dose); Biological: SMUP-IA-01(mid-dose); Biological: SMUP-IA-01(high-dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04339504

MP-SMUP-IA-P01-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 I trial (NCT04037345 ) will be followed-up until 60 months.

Full description

The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.

Enrollment: 12 estimated 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 I clinical trial.
2. Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.

Exclusion criteria

1. Subjects who were not enrolled in phase 1 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: None (Open label)

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12 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)

SMUP-IA-01(high-dose)

Experimental group

Description:

A single knee administration of SMUP-IA-01 (high-dose, 2.0 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(high-dose)