Osteoarthritis, KneePhase 1NCT04893174
Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA).
A Phase 1 study testing UMC119-06-05 and Hyaluronic acid in people with Osteoarthritis, Knee, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.
Trial summary
The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA). This will be a dose escalation, open label, single-center study in adult with mild to moderate knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- UMC119-06-05 and Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2022to Jun 2025
- Phase
- Phase 1
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory subjects with osteoarthritis of the knee with symptoms for at least 3 months, that may be taking conservative therapy (e.g. oral anti-inflammatory medication), and/or undergoing physical therapy. In subjects with bilateral knee osteoarthritis, the more symptomatic knee will be the target knee.
- Subjects of age between ≥40 through ≦ 90 years.
- Subject diagnosed with knee osteoarthritis of grade II and III according to the Kellgren-Lawrence Grading Scale on the target knee.
- Subject with joint pain equal or greater than 7 (total pain score 24 point) on the target knee assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
- Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, and the subject must agree within at least 4 weeks after the study administration to use a double barrier method of birth control.UNLESS they meet the following criteria:(1) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/mL, OR; (2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
- If a male and heterosexually active with a female of childbearing potential, the subject must agree within at least 4 weeks after the study administration to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm.
Who cannot join
- Subjects with body mass index (BMI) over 40.
- Subjects with knee deformity (knee varus or valgus greater than 10 degrees) on the target knee.
- Subjects with acute inflammation or tense effusion (e.g., infection), or bleeding on the target knee as judged by principal investigator (PI).
- Subjects with ligament instability (cruciate ligaments or collateral ligaments) or ligament laxity of the target knee as judged by PI.
- Subjects with a history of surgery of articular injury, ligament reconstruction and meniscus repair on the target knee joint within previous 6 months.
- Subjects with history of arthroscopic surgery in the target knee in the past 6 months or planned to have arthroscopy surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
Show all 38Show fewer
- Subjects with history of knee replacement procedure on the target knee.
- Subjects with intra-articular infiltration of any treatments on the target knee (such as hyaluronic acid, corticosteroids or platelet rich plasma (PRP)) in the last 3 months prior to study inclusion.
- Subjects with known history of osteoarthritis of hip or ankle.
- Subjects with known history of any systemic autoimmune rheumatic disease including but not limited to: Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis.
- Subjects with Rheumatoid Factor levels (>15.9 IU/mL) in laboratory tests.
- Subjects with joint diseases (except knee osteoarthritis) or infectious arthritis on the target knee considered by investigator not eligible to enter the study.
- Subjects who are known to be infected with HIV.
- Subjects with active hepatitis B or active hepatitis C.
- Subjects who have a significant concomitant illness as judged by principal investigator (PI) including, but not limited to:
- Severe renal insufficiency (eGFR < 30 mL/min/1.73 m2); or
- hepatic (e.g. Child-Pugh Class C); or
- Severe congestive heart failure (NYHA class 3 and 4); or
- Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease (COPD) and history of lung resection; or
- Any type of malignancy; or
- Uncontrolled Diabetes Mellitus (HbA1c > 10%)
- Subjects with uncorrected hematology test including, but not limited to:
- Hemoglobin < 8 g/dl; or
- White blood cell count < 3,000/mm3; or
- International normalized ratio (INR) of Coagulopathy >1.5; or
- Platelet count < 80,000/mm3
- Subjects who have the following conditions in laboratory tests:
- >2 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ; or
- Total bilirubin > 1.5 mg/dl
- Subjects with known history of allergy or hypersensitivity to any component of investigational product, including dimethyl sulfoxide, cell therapies, or hyaluronic acid.
- Subjects with known history of allergy or hypersensitivity to any concomitant medications, or rescue medications.
- Subjects who have a significant skin disease at the injection site on target knee as judged by principal investigator (PI).
- Subjects who are pregnant (or planning to become pregnant within 2 years of investigational product treatment) or lactating.
- Participation in another clinical trial or treatment (e.g., immunosuppressant therapies, systemic steroids, cytotoxic drugs, chemotherapy, radiation therapy, new investigational drugs or cell therapy) within 3 months prior to inclusion in the study.
- Contraindication to MRI:
- Indwelling medical devices such as pacemakers, aneurysm clip, etc.
- Indwelling metal from any other cause (trauma, etc.). To be excluded with history and/or radiographs, as necessary
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110301
Claire Liao, MS, +886-2-8978-7777 ext. 19965, Claire.Liao@meridigen.com
Joseph Chen, MS, +886-2-8978-7777 ext. 19905, joseph.chen@meridigen.com
About this study
Official title: A Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety and Tolerability After Intra Articular (IA) Injection of UMC119-06-05 in Adult Subjects With Mild to Moderate Knee Osteoarthritis(KOA).
The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA). This will be a dose escalation, open label, single-center study in adult with mild to moderate knee osteoarthritis. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of knee osteoarthritis.
Read the detailed description
Knee osteoarthritis (KOA), also known as degenerative joint disease, is the most common type of arthritis diagnosed. KOA is typically the result of wear and tear and progressive loss of articular cartilage. The prevalence of the Knee osteoarthritis will continue to increase as life expectancy and obesity rises. Osteoarthritis is typically a progressive disease that may eventually lead to disability. The intensity of the clinical symptoms may vary from each individual. However, they typically become more severe, more frequent, and more debilitating over time.The intensity of the clinical symptoms may vary from each individual. However, they typically become more severe, more frequent, and more debilitating over time.
The rate of progression also varies for each individual. Common clinical symptoms include knee pain that is gradual in onset and worse with activity, knee stiffness and swelling, pain after prolonged sitting or resting, and pain that worsens over time. Treatment for knee osteoarthritis begins with conservative methods and progresses to surgical treatment options when conservative treatment fails. While medications can help slow the progression of RA and other inflammatory conditions, no proven disease-modifying agents for the treatment of knee osteoarthritis currently exist. Among the more innovative, experimental therapies, mesenchymal stromal cells (MSCs) are proposed as a novel therapy with potential in treatment of KOA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- UMC119-06-05, Hyaluronic acid
- Keywords
- KOA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMC119-06-05Biological
Subjects will receive a single-dose IA injection of UMC119-06-05 followed by an IA injection of hyaluronic acid.
Cohort 1: Low does UMC119-06-05 Cohort 2: High does UMC119-06-05
Hyaluronic acidDevice
IA injection of hyaluronic acid.
| Study group | Role | What they receive |
|---|---|---|
| UMC119-06-05 | Experimental | Human Umbilical Cord Derived-Mesenchymal Stem Cells. Subjects will receive a single-dose intra-articular (IA) injection of UMC119-06-05 followed by an IA injection of hyaluronic acid. Receives: Biological: UMC119-06-05; Device: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and frequency of adverse events related to administration of UMC119-06-05.
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).
Measured: 1 months from the day of administration
Secondary outcomes (5)
Changes of total score in the Western Ontario and McMaster (WOMAC) assessment on the target knee.
Improvement in total score (pain subscale, and stiffness subscale, and physical function subscale) as assessed by mean change in WOMAC index.
Measured: from baseline up to 52 weeks after administration
Changes of arthritis pain on target knee using the 100-mm visual-analogue scale (VAS).
VAS scale range 0 to 100 mm, with higher scores indicates greater pain intensity. A decrease in score represents a decrease in disease related pain of knee.
Measured: from baseline up to 52 weeks after administration
Whole Organ Magnetic Resonance Imaging Score (WORMS).
Changes on the target knee for knee cartilage and the joint soft tissues assessed by Whole Organ Magnetic Resonance Imaging Score (WORMS) using magnetic resonance imaging (MRI) of T2 mapping.
Measured: from baseline up to 52 weeks after administration
Changes in Kellgren-Lawrence (K-L) grading and joint space on target knee.
The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria. Changes from baseline to post-treatment visits on the target knee for Kellgren-Lawrence (K-L) grading and joint space in X-ray examination results.
Measured: from baseline up to 52 weeks after administration
Amount of rescue medications required.
Total amount of acetaminophen or non-steroidal anti-inflammatory drugs (NSAID)
Measured: at first 4 weeks, first 28 weeks and the whole study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start15 Sep 2022
- Primary completionSep 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Cohort 1 : Low does UMC119-06-05 + Hyaluronic acid； Cohort 2 : High does UMC119-06-05 + Hyaluronic acid
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meridigen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893174
- Sponsor's protocol ID
- UMC119-06-05-KOA-01
- Status last verified
- Dec 2022
- First submitted
- 4 May 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety and Tolerability After Intra Articular (IA) Injection of UMC119-06-05 in Adult Subjects With Mild to Moderate Knee Osteoarthritis(KOA).
- ClinicalTrials.gov ID
- NCT04893174
- Acronym / sponsor ID
- UMC119-06-05-KOA-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- KOA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Meridigen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 May 2021 (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.
The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA). This will be a dose escalation, open label, single-center study in adult with mild to moderate knee osteoarthritis. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of knee osteoarthritis.
Detailed description
Knee osteoarthritis (KOA), also known as degenerative joint disease, is the most common type of arthritis diagnosed. KOA is typically the result of wear and tear and progressive loss of articular cartilage. The prevalence of the Knee osteoarthritis will continue to increase as life expectancy and obesity rises. Osteoarthritis is typically a progressive disease that may eventually lead to disability. The intensity of the clinical symptoms may vary from each individual. However, they typically become more severe, more frequent, and more debilitating over time.The intensity of the clinical symptoms may vary from each individual. However, they typically become more severe, more frequent, and more debilitating over time.
The rate of progression also varies for each individual. Common clinical symptoms include knee pain that is gradual in onset and worse with activity, knee stiffness and swelling, pain after prolonged sitting or resting, and pain that worsens over time. Treatment for knee osteoarthritis begins with conservative methods and progresses to surgical treatment options when conservative treatment fails. While medications can help slow the progression of RA and other inflammatory conditions, no proven disease-modifying agents for the treatment of knee osteoarthritis currently exist. Among the more innovative, experimental therapies, mesenchymal stromal cells (MSCs) are proposed as a novel therapy with potential in treatment of KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort 1 : Low does UMC119-06-05 + Hyaluronic acid； Cohort 2 : High does UMC119-06-05 + Hyaluronic acid
| Arm | Type | Receives |
|---|---|---|
| UMC119-06-05 | Experimental | Biological: UMC119-06-05, Device: Hyaluronic acidHuman Umbilical Cord Derived-Mesenchymal Stem Cells. Subjects will receive a single-dose intra-articular (IA) injection of UMC119-06-05 followed by an IA injection of hyaluronic acid. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ambulatory subjects with osteoarthritis of the knee with symptoms for at least 3 months, that may be taking conservative therapy (e.g. oral anti-inflammatory medication), and/or undergoing physical therapy. In subjects with bilateral knee osteoarthritis, the more symptomatic knee will be the target knee.
- Subjects of age between ≥40 through ≦ 90 years.
- Subject diagnosed with knee osteoarthritis of grade II and III according to the Kellgren-Lawrence Grading Scale on the target knee.
- Subject with joint pain equal or greater than 7 (total pain score 24 point) on the target knee assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
Key exclusion criteria (38 listed)
- Subjects with body mass index (BMI) over 40.
- Subjects with knee deformity (knee varus or valgus greater than 10 degrees) on the target knee.
- Subjects with acute inflammation or tense effusion (e.g., infection), or bleeding on the target knee as judged by principal investigator (PI).
- Subjects with ligament instability (cruciate ligaments or collateral ligaments) or ligament laxity of the target knee as judged by PI.
- Subjects with a history of surgery of articular injury, ligament reconstruction and meniscus repair on the target knee joint within previous 6 months.
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 |
|---|---|---|
| UMC119-06-05Subjects will receive a single-dose IA injection of UMC119-06-05 followed by an IA injection of hyaluronic acid. Cohort 1: Low does UMC119-06-05 Cohort 2: High does UMC119-06-05 | Biological | UMC119-06-05 |
| Hyaluronic acidIA injection of hyaluronic acid. | Device | UMC119-06-05 |
Primary outcome
The incidence and frequency of adverse events related to administration of UMC119-06-05.
Time frame: 1 months from the day of administration
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).
5 secondary outcomes
Changes of total score in the Western Ontario and McMaster (WOMAC) assessment on the target knee.
Time frame: from baseline up to 52 weeks after administration
Changes of arthritis pain on target knee using the 100-mm visual-analogue scale (VAS).
Time frame: from baseline up to 52 weeks after administration
Whole Organ Magnetic Resonance Imaging Score (WORMS).
Time frame: from baseline up to 52 weeks after administration
Changes in Kellgren-Lawrence (K-L) grading and joint space on target knee.
Time frame: from baseline up to 52 weeks after administration
Amount of rescue medications required.
Time frame: at first 4 weeks, first 28 weeks and the whole study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UMC119-06-05 and Hyaluronic acid in people with Osteoarthritis, Knee, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.
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 7 inclusion and 38 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 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
What does this 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.
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 Claire Liao, MS (+886-2-8978-7777 ext. 19965, claire.liao@meridigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and frequency of adverse events related to administration of UMC119-06-05. (time frame: 1 months from the day of administration). 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 4 Dec 2023.