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Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FURESTEM-OA Kit Inj.
Placebo
Sponsored by
Kang Stem Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    FURESTEM-OA Kit Inj.

    Placebo

    Arm Description

    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.

    Product name: Placebo of FURESTEM-OA Kit Inj. (placebo administration in Phase 2a clinical trial)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) score
    Rate and amount of changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Changes in 100 mm VAS score
    Changes in the International Knee Documentation Committee Scoring System (IKDC) score
    Evaluation of K&L grade
    Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
    Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
    Rate and amount of changes in biomarker values

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Kang Stem Biotech Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05944627
    Brief Title
    Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 6, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    February 28, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kang Stem Biotech Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    FURESTEM-OA Kit Inj., Knee Osteoarthritis Stem cell

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Phase 1 clinical trial was an open-label. Phase 2a clinical trial was conducted in a single-blind.
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FURESTEM-OA Kit Inj.
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Product name: Placebo of FURESTEM-OA Kit Inj. (placebo administration in Phase 2a clinical trial)
    Intervention Type
    Biological
    Intervention Name(s)
    FURESTEM-OA Kit Inj.
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo administration in Phase 2a clinical trial
    Primary Outcome Measure Information:
    Title
    Assessment of safety and tolerability of FURESTEM-OA Kit Inj.
    Description
    Maximum Tolerated Dose (MTD) identification based on Dose Limiting Toxicities (DLTs) evaluation Evaluation of adverse events
    Time Frame
    4 weeks follow-up after treatment
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Evaluation of K&L grade
    Time Frame
    week 24 after treatment
    Title
    Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
    Time Frame
    week 24 after treatment
    Title
    Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
    Time Frame
    week 24 after treatment
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 Exclusion Criteria: 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: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Insun Baek
    Phone
    02-888-1590
    Email
    isbaek@kangstem.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyeseung Jeon
    Phone
    02-888-1590
    Email
    hsjeon@kangstem.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyoung-Ho Yoon, professor (CI)
    Organizational Affiliation
    Kyung Hee University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sang Hak Lee, professor
    Organizational Affiliation
    Gangdong Kyunghee University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluate Safety and Explore Efficacy of FURESTEM-OA Kit Inj. in Patients With Knee Osteoarthritis

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