NCT06013306

Brief Summary

Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
56mo left

Started Sep 2023

Longer than P75 for all trials

Status
not yet recruiting

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

Study Progress37%
Sep 2023Dec 2030

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

September 14, 2023

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

6.2 years

First QC Date

August 22, 2023

Last Update Submit

August 28, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Number of AESI

    5 years follow-up after treatment

  • Number of SS

    5 years follow-up after treatment

Secondary Outcomes (7)

  • Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment

  • Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)

    1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment

  • Changes in 100-mm VAS

    1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment

  • Changes in International Knee Documentation Committee Scoring System (IKDC)

    1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment

  • Evaluation of International K&L grade(X-ray)

    1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment

  • +2 more secondary outcomes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj

You may qualify if:

  • Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
  • Those who understand and voluntarily sign an informed consent form

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kyoung-Ho Yoon, professor (CI)

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

  • Sang Hak Lee, professor

    Gangdong Kyunghee University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaeeun JEON

CONTACT

02-2036-7614cejeon@kangstem.com

Hyeseung JEON

CONTACT

02-888-1592hsjeon@kangstem.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

September 14, 2023

Primary Completion (Estimated)

November 7, 2029

Study Completion (Estimated)

December 30, 2030

Last Updated

August 30, 2023

Record last verified: 2023-08