Clinical trial NCT06798727: Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
Official title: Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: human umbilical cord blood derived mesenchymal stem cells
hUC-MSCs
Knee Osteoarthritis
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2's long term follow-up Study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of total score in WOMAC (Western Ontario and McMaster University)
timeFrame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
Secondary outcomes:
measure: Change of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's baseline.
timeFrame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
measure: Change of score in 100 mm VAS (Visual Analogue Scale)
timeFrame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
measure: Change of score in IKDC(International Knee Documentation Committee)
timeFrame: Time Frame: Month 12, 24, 36, 48 and 60 after treatment
measure: Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
timeFrame: Time Frame: Month 12 and 24 after treatment
measure: Change in K&L(Kellgren-Lawrence) grade
timeFrame: Time Frame: Month 12, 24 and 60 after treatment
measure: Change in joint space width
timeFrame: Time Frame: Month 12, 24 and 60 after treatment
measure: Change in mechanical axis, anatomical axis
timeFrame: Time Frame: Month 12, 24 and 60 after treatment
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul Nation University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospita
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: