NCT04339504

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 I trial (NCT04037345 ) will be followed-up until 60 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 14, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

5.6 years

First QC Date

April 6, 2020

Last Update Submit

March 13, 2023

Conditions

Knee Osteoarthritis

Keywords

human umbilical cord blood derived mesenchymal stem cellsKnee 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).

    Month 12, 24, 36, 48 and 60 after treatment

Secondary Outcomes (9)

  • Change of score in WOMAC three subscales (Pain, stiffness, physical function)

    Month 12, 24, 36, 48 and 60 after treatment

  • Change of score in 100 mm VAS (Visual Analogue Scale)

    Month 12, 24, 36, 48 and 60 after treatment

  • Change of score in IKDC(International Knee Documentation Committee)

    Month 12, 24, 36, 48 and 60 after treatment

  • Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)

    Month 12 and 24 after treatment

  • Change in K&L(Kellgren-Lawrence) grade

    Month 12 and 24 after treatment

  • +4 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)

SMUP-IA-01(high-dose)

EXPERIMENTAL

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)

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

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)
SMUP-IA-01(high-dose)BIOLOGICAL

A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)

SMUP-IA-01(high-dose)

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

You may not qualify if:

  • Subjects who were not enrolled in phase 1 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 (1)

Seoul national University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Myungchul LEE, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunyoung LEE

CONTACT

82234656748ley0113@medi-post.co.kr

Jungjin Park

CONTACT

82234656641jjpark@medi-post.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

April 14, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)