CClinicalTrials.gg
Sign In
RecruitingNCT07754175Updated Aug 10, 2026

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

An observational study in Knee Osteoarthritis, sponsored by Kang Stem Biotech Co., Ltd.. Recruiting at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Kang Stem Biotech Co., Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
36
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • FURESTEM-OA Kit Inj.
  • Knee Osteoarthritis Stem cell
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants who received placebo in the K0701 clinical trial, completed the long-term follow-up study, and voluntarily provided written informed consent to participate in this extension study.

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
36 participants (estimated)
Patient registry
No
05

What researchers measure

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

06

Study locations

1 of 2 sites recruiting
  • CHA University Bundang Medical Center
    Seoul, South Korea
    • Jae Young Park, professor · Contact
    Recruiting
  • Kyung Hee University Hospital
    Seoul, South Korea
    • Kyoung Ho Yoon Yoon, professor · Principal investigator
    Not yet recruiting
07

Registry details

Key details

Study ID
NCT07754175
Lead sponsor
Kang Stem Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Jul 20, 2026
Primary completion
Dec 31, 2031 (estimated)
Completion
Feb 28, 2032 (estimated)
Last update
Aug 10, 2026

Study contacts

Moonkyoung Kim
Contact
mkkim@kangstem.com
02-2036-7526
Yeonsil Yu
Contact
yuys@kangstem.com
02-2036-7571
Kyoung Ho Yoon, professor (CI)
principal investigator · Kyung Hee University Hospital
Sang Hak Lee, professor
principal investigator · Gangdong Kyunghee University Hospital
Jang Ki Mo, professor
principal investigator · Korea University Anam Hospital
Sang Gyun Kim, professor
principal investigator · National medical center
Seok jung Kim, professor
principal investigator · The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Jae Young Park, professor
principal investigator · CHA University Bundang Medical Center
Sung Hwan Kim, professor
principal investigator · Severance Hospital, Yonsei University College of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoarthritis, Knee→

Other studies from this sponsor

Kang Stem Biotech Co., Ltd.

Start the discussion