Knee OsteoarthritisPhase 1/2NCT05944627
Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis
A Phase 1/2 study testing FURESTEM-OA Kit Inj. in people with Knee Osteoarthritis, run by Kang Stem Biotech Co., Ltd..
Trial summary
A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients with Knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- FURESTEM-OA Kit Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2023to 28 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adult men and women over 19 years of age
- Those with a body mass index (BMI) of less than 30 kg/m2 at screening
- Those classified as ICRS grade 3 or 4 according to the International Cartilage Repair Society (ICRS) rating system through MRI examination at the time of screening
- Those diagnosed with knee osteoarthritis according to the diagnosis criteria of the American College of Rheumatology (ACR) at the time of screening
- Those diagnosed with Kellgren-Lawrence (K\&L) grade 2-3 knee osteoarthritis (OA) at the time of screening
- Those who do not have clinically significant abnormalities in the results of physical examination, hematologic test, blood chemistry test, or urine test
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- Those whose symptoms (pain, etc.) do not improve despite conservative therapy (drug therapy, physical therapy, etc.) for at least 12 weeks
- Those with a 100 mm Visual Analogue Scale (VAS) score* for pain at the time of screening of 50 mm or more
- Those who have heard and fully understood the detailed description of this clinical trial and have voluntarily decided to participate and agreed in writing to comply with the precautions
Who cannot join
- Those who have participated in at least one other clinical trial within 4 weeks before screening and received drugs (based on the last administration date), or received medical device treatment for clinical trials
- Those diagnosed with Kellgren-Lawrence (K\&L) grade 4 knee osteoarthritis (OA) at the time of screening
- At the time of screening, those with the results of the physical examination showing grade III (grade 0: none, grade I: 0~5 mm, grade II: 5~10 mm, grade III: >10 mm) or more ligament instability
- Patients with osteochondritis dissecans
- Those with hypersensitivity reactions or allergies to components of the investigational product, FURESTEM-OA Kit Inj. (combination of (FURESTEM-OA Inj.)(solution 1) + (CAM Inj.)(solution 2))
- Those with the following confirmed medical history or surgical history / procedure history at the time of screening:
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- Patients with a history of procedure or surgery (including arthroscopy) on the target knee within 24 weeks prior to the baseline visit (Visit 2)
- Patients who have undergone a knee joint replacement
- Those with any of the following diseases at the time of screening:
- Those with active infectious disease (hepatitis A/B/C (including carriers) or HIV infection that in the opinion of the investigator render those subjects as unfit to participate in this clinical trial. However, those who test positive by vaccination may participate.)
- Those who have been determined by the investigator as having difficulty participating in this clinical trial due to a severe chronic disease (cardiovascular disease, metabolic disease, renal dysfunction, etc., excluding controlled hypertension)
- Those with a skin disease or infection on the skin surface at the site where the investigational product is to be administered
- Those with severe pain in other areas that may affect the determination of symptoms in the knee joint (e.g., patients with poly-articular joint pain with severe osteoarthritis symptoms in other areas (such as the hip joint))
- Patients with other joint diseases, such as inflammatory joint diseases including rheumatoid arthritis, or infectious joint diseases such as septic arthritis, gout, recurrent pseudogout, joint fracture, acromegaly, Wilson's disease, primary osteochondrosis
- Patients with secondary osteoarthritis due to systemic diseases such as ochronosis or hemochromatosis
- Patients with genetic diseases such as hyperkinesia or collagen gene abnormalities
- Patients with severe painful conditions such as Sudeck's atrophy, Paget's disease, or spinal disc herniation
- Those with any of the following drug administration/treatment history:
- If herbal drugs (for osteoarthritis treatment), glucosamine, chondroitin, anti-inflammatory drugs, patches, and/or other external preparations were administered within 14 days prior to the baseline visit (Visit 2) (However, participation in the clinical trial may be allowed after a sufficient wash-out period, and for glucosamine and chondroitin, participation in clinical trials is possible for health functional foods only if continuously administered from 4 weeks before screening)
- Those who have been given drugs through intra-articular injection A. Patients who received hyaluronic acid (HA) in the target joint cavity within 12 weeks of screening B. Patients who received steroids in the target joint cavity within 12 weeks of screening C. Patients who systemically used steroids within 4 weeks of screening (except for topical application and inhalation)
- Those who have performed physical therapy or oriental medical treatment (acupuncture, swelling, moxibustion, etc.) by a specialist for the purpose of relieving pain within 14 days prior to the baseline visit (Visit 2)
- Those who have been given an analgesic within 14 days before administration of the investigational product, or within a time period 5 times the half-life of the analgesic.
- Those who have been given an immunosuppressive drug (cyclosporin A or azathioprine) including antirheumatic drug (including methotrexate or antimetabolite) within 12 weeks prior to the baseline visit (Visit 2)
- Those who have been given an anesthetic within 2 days prior to the baseline visit (Visit 2)
- Those who have had gene therapy or cytotherapy for treatment of the knee joint
- Those who fall under the following laboratory test results at the time of screening:
- Serum creatinine > 2.0 mg/dL renal dysfunction
- AST or ALT test result is more than 2.5 times the upper limit of the normal range
- Patients with a malignant tumor (However, in the following cases, participation in the clinical trial may be allowed.)
- Those who have been diagnosed with complete remission at least 5 years after completion of treatment for the tumor
- If at least 1 year has elapsed since complete resection of a basal cell carcinoma/squamous cell carcinoma, radical resection of papillary thyroid cancer, or successful treatment of cervical epithelial cancer
- Women and men of childbearing potential who are pregnant, nursing, or do not agree to perform appropriate contraception
- Hormonal contraception (cutaneous patch, injection, oral contraceptive, etc.), intrauterine devices (loop, intrauterine system containing hormone), sterilization procedure for oneself or spouse (or partner) (vasectomy, tubal ligation, etc.), double blocking (both male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap) must use a contraceptive device), etc.
- Those with a history of alcohol and drug abuse within one year prior to screening
- For other reasons, those deemed inappropriate to participate in clinical trials according to the judgment of investigators
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis
A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients with Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Being tested
- FURESTEM-OA Kit Inj., Placebo
- Keywords
- FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-OA Kit Inj.Biological
FURESTEM-OA Kit Inj. is a combination medical product in which FURESTEM-OA Inj. (solution 1) is the primary mode of action and CAM Inj. (solution 2) acts as an auxiliary. The product is administered after mixing solution 1 and solution 2.
PlaceboBiological
placebo administration in Phase 2a clinical trial
| Study group | Role | What they receive |
|---|---|---|
| FURESTEM-OA Kit Inj. | Experimental | Subjects are slowly administered FURESTEM-OA Kit Inj. once into the knee joint cavity contained in a disposable sterile syringe mixed with Solution 1 and Solution 2 depending on the dose group assigned at the baseline (Visit 2).
The subjects are assigned sequentially to the following 3 dose groups in Phase 1 clinical trial, and in Phase 2a clinical trial, the subjects are randomized to 1-2 dose groups below MTD determined in Phase 1. Receives: Biological: FURESTEM-OA Kit Inj. |
| Placebo | Placebo comparator | Product name: Placebo of FURESTEM-OA Kit Inj. (placebo administration in Phase 2a clinical trial) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of FURESTEM-OA Kit Inj.
Maximum Tolerated Dose (MTD) identification based on Dose Limiting Toxicities (DLTs) evaluation Evaluation of adverse events
Measured: 4 weeks follow-up after treatment
Secondary outcomes (8)
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) score
Measured: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Rate and amount of changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Changes in 100 mm VAS score
Measured: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Changes in the International Knee Documentation Committee Scoring System (IKDC) score
Measured: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Evaluation of K&L grade
Measured: week 24 after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Measured: week 24 after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
Measured: week 24 after treatment
Rate and amount of changes in biomarker values
Measured: week 1, week 4, week 8, week 12, week 16, week 20 and week 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 posted13 Jul 2023
- Study start6 Jul 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion28 Feb 2026 (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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 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
- NCT05944627
- Sponsor's protocol ID
- K0701
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Jul 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05944627
- Acronym / sponsor ID
- K0701
- Conditions
- Knee Osteoarthritis
- Keywords
- FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 13 Jul 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.
A Single, Dose Escalation, Optimal Dose Finding Phase I/IIa Clinical Trial to Evaluate Safety and Explore Efficacy of the Single Treatment of FURESTEM-OA Kit Inj. in Patients with Knee Osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FURESTEM-OA Kit Inj. | Experimental | Biological: FURESTEM-OA Kit Inj.Subjects are slowly administered FURESTEM-OA Kit Inj. once into the knee joint cavity contained in a disposable sterile syringe mixed with Solution 1 and Solution 2 depending on the dose group assigned at the baseline (Visit 2). The subjects are assigned sequentially to the following 3 dose groups in Phase 1 clinical trial, and in Phase 2a clinical trial, the subjects are randomized to 1-2 dose groups below MTD determined in Phase 1. |
| Placebo | Placebo comparator | Biological: PlaceboProduct name: Placebo of FURESTEM-OA Kit Inj. (placebo administration in Phase 2a clinical trial) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men and women over 19 years of age
- Those with a body mass index (BMI) of less than 30 kg/m2 at screening
- Those classified as ICRS grade 3 or 4 according to the International Cartilage Repair Society (ICRS) rating system through MRI examination at the time of screening
- Those diagnosed with knee osteoarthritis according to the diagnosis criteria of the American College of Rheumatology (ACR) at the time of screening
- Those diagnosed with Kellgren-Lawrence (K\&L) grade 2-3 knee osteoarthritis (OA) at the time of screening
Key exclusion criteria (35 listed)
- Those who have participated in at least one other clinical trial within 4 weeks before screening and received drugs (based on the last administration date), or received medical device treatment for clinical trials
- Those diagnosed with Kellgren-Lawrence (K\&L) grade 4 knee osteoarthritis (OA) at the time of screening
- At the time of screening, those with the results of the physical examination showing grade III (grade 0: none, grade I: 0~5 mm, grade II: 5~10 mm, grade III: >10 mm) or more ligament instability
- Patients with osteochondritis dissecans
- Those with hypersensitivity reactions or allergies to components of the investigational product, FURESTEM-OA Kit Inj. (combination of (FURESTEM-OA Inj.)(solution 1) + (CAM Inj.)(solution 2))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FURESTEM-OA Kit Inj.FURESTEM-OA Kit Inj. is a combination medical product in which FURESTEM-OA Inj. (solution 1) is the primary mode of action and CAM Inj. (solution 2) acts as an auxiliary. The product is administered after mixing solution 1 and solution 2. | Biological | FURESTEM-OA Kit Inj. |
| Placeboplacebo administration in Phase 2a clinical trial | Biological | Placebo |
Primary outcome
Assessment of safety and tolerability of FURESTEM-OA Kit Inj.
Time frame: 4 weeks follow-up after treatment
Maximum Tolerated Dose (MTD) identification based on Dose Limiting Toxicities (DLTs) evaluation Evaluation of adverse events
8 secondary outcomes
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) score
Time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Rate and amount of changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Changes in 100 mm VAS score
Time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Changes in the International Knee Documentation Committee Scoring System (IKDC) score
Time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Evaluation of K&L grade
Time frame: week 24 after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Time frame: week 24 after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
Time frame: week 24 after treatment
Rate and amount of changes in biomarker values
Time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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. This study is not recruiting at the moment.
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?
A Phase 1/2 study testing FURESTEM-OA Kit Inj. in people with 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 9 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 14 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Insun Baek (02-888-1590, isbaek@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety and tolerability of FURESTEM-OA Kit Inj. (time frame: 4 weeks 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 14 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.