Knee OsteoarthritisNCT06013306
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
An observational study of Knee Osteoarthritis, run by Kang Stem Biotech Co., Ltd..
Trial summary
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2023to 30 Dec 2030
- 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: Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
Who may be able to join
- Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
- Those who understand and voluntarily sign an informed consent form
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AESI
Measured: 5 years follow-up after treatment
Number of SS
Measured: 5 years follow-up after treatment
Secondary outcomes (7)
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The higher the score, the worse the condition of the disease is.
Measured: 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)
The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.
Measured: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in 100-mm VAS
Measured: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in International Knee Documentation Committee Scoring System (IKDC)
A higher score indicates better function and less symptomatic
Measured: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Evaluation of International K&L grade(X-ray)
Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends
Measured: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
A higher score indicates better function and less symptomatic
Measured: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
The higher the score means normal state.
Measured: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start14 Sep 2023 (estimated)
- Primary completion7 Nov 2029 (estimated)
- Study completion30 Dec 2030 (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
- 58 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013306
- Sponsor's protocol ID
- K0701-E
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
- ClinicalTrials.gov ID
- NCT06013306
- Acronym / sponsor ID
- K0701-E
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (estimated)
- Primary completion
- 7 Nov 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 28 Aug 2023 (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.
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study
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
- Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
Key inclusion criteria (2 listed)
- Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
- Those who understand and voluntarily sign an informed consent form
Key exclusion criteria (1 listed)
- None
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
Number of AESI
Time frame: 5 years follow-up after treatment
Number of SS
Time frame: 5 years follow-up after treatment
7 secondary outcomes
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 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)
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in 100-mm VAS
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in International Knee Documentation Committee Scoring System (IKDC)
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Evaluation of International K&L grade(X-ray)
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) 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 30 Aug 2023.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Kang Stem Biotech Co., Ltd..
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 1 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: opening soon, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Chaeeun JEON (02-2036-7614, cejeon@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of AESI (time frame: 5 years follow-up after treatment). The study lists 2 primary outcomes in all. 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 30 Aug 2023.