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NCT Number: NCT07754175

A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial

A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial

Recruiting

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHA University Bundang Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who received placebo in the K0701 clinical trial and completed the Long-term follow-up study
  • Participants who voluntarily provide written informed consent to participate in this extension study

Exclusion criteria

Participants meeting any of the following criteria:

  • Participants whom the investigator considers unsuitable for participation in this extension study.
  • Pregnant or breastfeeding women, and women of childbearing potential or men who do not agree to use an appropriate method of contraception during the study

Treatment and study plan

Primary outcomes

  1. Incidence of Adverse Event, AESI(Adverse Event of Special Interest)

    Time frame: 5 years follow-up after treatment

Secondary outcomes

  1. Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

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

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  3. Changes in 100-mm VAS

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  4. Changes in International Knee Documentation Committee Scoring System (IKDC)

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

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

    Time frame: Month 12, Month 24 after treatment

  6. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)

    Time frame: Month 12, Month 24 after treatment

  7. Whole-Organ Magnetic Resonance Imaging Score (WORMS) score

    Time frame: Month 12, Month 24 after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Moonkyoung Kim

CONTACT

[email protected]

02-2036-7526

Yeonsil Yu

CONTACT

[email protected]

02-2036-7571

Sponsors and collaborators

Lead sponsor

Kang Stem Biotech Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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