Knee OsteoarthritisNCT07754175
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 of Knee Osteoarthritis, run by Kang Stem Biotech Co., Ltd. at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 36 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Jul 2026to 28 Feb 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
CHA University Bundang Medical Center
Seoul
Jae Young Park, professor
- Not yet recruiting
Kyung Hee University Hospital
Seoul
Kyoung Ho Yoon Yoon, professor
About this study
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
- Conditions
- Knee Osteoarthritis
- Keywords
- FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Event, AESI(Adverse Event of Special Interest)
Measured: 5 years follow-up after treatment
Secondary outcomes (7)
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Measured: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in 100-mm VAS
Measured: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in International Knee Documentation Committee Scoring System (IKDC)
Measured: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Evaluation of International K&L grade(X-ray)
Measured: Month 12, Month 24 after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
Measured: Month 12, Month 24 after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
Measured: Month 12, Month 24 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start20 Jul 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion28 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoung Ho Yoon, professor (CI), Principal investigator, Kyung Hee University HospitalSang Hak Lee, professor, Principal investigator, Gangdong Kyunghee University HospitalJang Ki Mo, professor, Principal investigator, Korea University Anam HospitalSang Gyun Kim, professor, Principal investigator, National medical centerSeok jung Kim, professor, Principal investigator, The Catholic University of Korea, Uijeongbu St. Mary's HospitalJae Young Park, professor, Principal investigator, CHA University Bundang Medical CenterSung Hwan Kim, professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754175
- Sponsor's protocol ID
- K0702
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07754175
- Acronym / sponsor ID
- K0702
- Conditions
- Knee Osteoarthritis
- Keywords
- FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 28 Feb 2032 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Event, AESI(Adverse Event of Special Interest)
Time frame: 5 years follow-up after treatment
7 secondary outcomes
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in 100-mm VAS
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in International Knee Documentation Committee Scoring System (IKDC)
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Evaluation of International K&L grade(X-ray)
Time frame: Month 12, Month 24 after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
Time frame: Month 12, Month 24 after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
Time frame: Month 12, Month 24 after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Kang Stem Biotech Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moonkyoung Kim (02-2036-7526, mkkim@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Event, AESI(Adverse Event of Special Interest) (time frame: 5 years follow-up after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.