Knee OsteoarthritisPhase 3NCT05526001
Efficacy and Safety of ELIXCYTE Intra-articular Injection in Subject With Knee Osteoarthritis
A Phase 3 study testing ELIXCYTE and Saline in people with Knee Osteoarthritis, run by UnicoCell Biomed CO. LTD at 4 sites in Taiwan.
Trial summary
This is a Phase III, double-blinded, placebo-controlled, multicenter study to investigate the efficacy and safety of a new study intervention, ELIXCYTE, compared to placebo (normal saline) in subjects with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ELIXCYTE and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 4 sitesTaiwan
- Study dates
- 3 Jul 2023to Nov 2026
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject is eligible for the study if all of the following apply:
- Either gender, aged 40 to 80
- With unilateral/bilateral knee OA of Kellgren-Lawrence grading II-III (determined by American College of Rheumatology criteria of knee OA).
- WOMAC pain score of 7 - 17 in the target knee even if treated with chronic doses of NSAID.
- Has received 1 - 3 types of pharmacological therapies for knee OA for more than 3 months but the symptoms have not relieved.
- Unwilling or not suitable to undergo knee surgery (including total knee replacement and knee arthroplasty).
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- Understands and has signed the informed consent form.
- With adequate hematological indices:
- White blood cell (WBC) ≥ 3,000/mm3
- Platelet count ≥ 80,000/μL
- With adequate coagulation indices: Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of the normal range (ULN).
- With adequate liver function where serum total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase (AST) ≤ 3 times ULN, and alanine aminotransferase (ALT) ≤ 3 times ULN.
- Has an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.
Who cannot join
- Any subject meeting any of the exclusion criteria will be excluded from study participation.
- With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction (with the exception of meniscal debridement), and knee arthroplasty on the target knee joint.
- With any IA intervention of the target knee within 3 months prior to screening (e.g. steroid, anesthetic), or sodium hyaluronate by IA intervention of the target knee within 6 months prior to screening.
- Administered systemic immunosuppressive agent, systemic antiinflammatory drug, systemic steroid, systemic analgesics (except acetaminophen, and tramadol as rescue medications), duloxetine, or over-the-counter medications contain analgesics (e.g. cold medicine) within 2 weeks prior to screening. Administered systemic herbal, homeopathic, or naturopathic remedies for knee OA within 2 weeks prior to screening. A subject requiring routine use of low-dose Aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded from this study
- Administered local immunosuppressive agent, local anti-inflammatory drug, local steroid, local analgesics, over-the-counter medications contain analgesics, herbal, homeopathic, or naturopathic remedies for knee OA within 2 weeks prior to screening.
- Has participated in other investigational studies within 4 weeks prior to screening.
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- Administered monoamine oxidase inhibitor, selective serotonin reuptake inhibitor, serotonin-norepinephrine reuptake inhibitors, benzodiazepine, or tricyclic antidepressants within 4 weeks prior to screening.
- With joint diseases expect knee OA that is considered not eligible to enter the study by the investigator.
- Systemic diseases that may affect joints, including but not limited to inflammatory joint diseases, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and fibromyalgia.
- Known or suspected infection around the target knee joint.
- Has serious medical conditions or ongoing disease (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject.
- With any evidence of malignant disease with a life expectancy less than 1 year.
- With a known history of human immunodeficiency virus (HIV) infection.
- With a known history of alcohol abuse.
- With a known history of opioid dependent.
- Known or suspected hypersensitivity to any ingredients of the investigational product (ELIXCYTE) or contrast medium for magnetic resonance imaging (MRI).
- Body mass index (BMI) ≥ 35 kg/m2
- Judged to be not applicable to this study by investigator such as the difficulty of follow-up observation.
- Has claustrophobia and/or cannot take MRI test.
- Has any existing active/inactive implanted medical devices that pose a safety risk during MRI examination, such as a cardiac pacemaker, cochlear, intracranial vascular clips, or neurostimulator, etc.
- Has any existing metallic intraocular foreign body that pose a safety risk during MRI examination.
- Female subject of childbearing potential who:
- Is lactating; or
- Has positive pregnancy test result at eligibility checking; or
- Refuses to adopt at least one form of birth control from signing informed consent to the end of the study.
- Male subject with female spouse/partner who is of childbearing potential refuses to adopt at least one form of birth control from signing informed consent to the end of the study.
- Known allergy to acetaminophen and tramadol.
- Has any abnormal radiographic evidence of target knee, such as excessive malalignment, other arthropathies, or systemic metabolic bone disease, etc.
- Known any contraindication to IA intervention of the target knee, such as skin infection of injection site, coagulopathy, or routine use of anticoagulant, etc.
- For exclusion criteria #21 and #22, acceptable forms of birth control include:
- Established use of oral, injected, or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps).
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Taipei Medical University Shuang-Ho Hospital
New Taipei City, Taiwan, 23561
Taipei Veterans General Hospital
Taipei, 112
National Taiwan University Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
Official title: A Phase III, Randomized, Parallel, Double-blinding, 2-Arm Study to Investigate the Efficacy and Safety of Intra-articular ELIXCYTE (Adipose-Derived Stem Cells) Injection Compared With Placebo in Subjects With Knee Osteoarthritis
This is a Phase III, double-blinded, placebo-controlled, multicenter study to investigate the efficacy and safety of a new study intervention, ELIXCYTE, compared to placebo (normal saline) in subjects with knee osteoarthritis. The primary hypothesis of the study is to demonstrate that ELIXCYTE is superior to placebo (saline) in improving knee pain on the target knee from baseline.
During the study, each participant will receive either ELIXCYTE (study intervention) or placebo (normal saline) intra-articular injection once on the target knee after eligibility criteria check. The target knee will be assessed by X-ray, MRI and subject self-evaluation knee questionnaires (WOMAC, KSS and KOOS) in the following visits. Other safety assessments, including lab test, physical examination, vital sign, medical/medication history and adverse events will also be collected throughout the study.
Read the detailed description
This Phase III study is a prospective, double-blind, parallel, multicenter, 2-arm study to evaluate the efficacy and safety of intra-articular ELIXCYTE injection compared to placebo in subjects with knee OA. All the subjects will be enrolled in Taiwan. Subjects aged 40 to 80 years with knee OA will be enrolled in the study. Approximately 165 eligible subjects will be randomized to receive either ELIXCYTE, or placebo in a 2:1 ratio.
The target population will be composed of subjects with unilateral or bilateral knee OA. For subjects with bilateral OA knees, only the knee with more severe symptoms will be selected as the target knee, while the non-target knee can continue the regular local treatment for ethical consideration. If the severities of the OA symptoms will be the same for both knees, the knee with more pain should be selected based on the WOMAC pain score. Eligible subjects will be randomized into one of the study groups (ELIXCYTE, or placebo in a 2:1 ratio).
The study consists of 9 visits and the duration per subject will be approximately 50 weeks (14 days of screening period, a treatment visit on Day 1, and 48 weeks of evaluation period). Unscheduled visit(s) may be arranged when deem necessary by the investigator.
In addition, if ELIXCYTE provided medical benefits with no safety issues to ELIXCYTE group at the end of week 48, subjects assigned to placebo group will be offered a treatment with ELIXCYTE under an extension study after study unblinding.
- Conditions
- Knee Osteoarthritis
- Being tested
- ELIXCYTE, Saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIXCYTEBiological
ELIXCYTE, a new investigational product developed by UnicoCell Biomed, contains allogenic Adipose-derived stem cells (ADSCs). The ADSCs of ELIXCYTE for subjects were obtained from donors, and the Sponsor followed the manufacturing and testing procedures described in chemistry, manufacturing and control (CMC) information in order to assure the quality of final products.
SalineDrug
Placebo control used in the study.
| Study group | Role | What they receive |
|---|---|---|
| ELIXCYTE | Experimental | Subjects will be intra-articular (IA) injected with 4 mL of ELIXCYTE (containing 32×10^6 ADSCs) at the target knee once Receives: Biological: ELIXCYTE |
| Placebo control (Saline) | Placebo comparator | Subjects will be intra-articular (IA) injected with 4 mL of saline at the target knee once Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of WOMAC pain score on the target knee
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a questionnaire to evaluate the condition of subjects with knee OA. The pain score ranges from 0 to 20.
Measured: Baseline, Week 24
Secondary outcomes (21)
Percentage of pain responders (WOMAC pain score)
The responders are defined as subjects who had at least a 20% reduction in WOMAC pain score from baseline.
Measured: Week 24 and Week 48
Total scores of WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a standardized questionnaire to evaluate the condition of subjects with knee OA in terms of pain, stiffness, and physical functioning of the joints. It contains 5 items for pain (score range 0 ~ 20), 2 for stiffness (score range 0 ~ 8), and 17 for functional limitation (score range 0 ~ 68). The total score of the question ranges from 0 to 96
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Pain subscale of WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a standardized questionnaire to evaluate the condition of subjects with knee OA in terms of pain, stiffness, and physical functioning of the joints. It contains 5 items for pain, and the total pain score ranges from 0 to 20.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Stiffness subscale of WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a standardized questionnaire to evaluate the condition of subjects with knee OA in terms of pain, stiffness, and physical functioning of the joints. It contains 2 items for stiffness, and the total stiffness score ranges from 0 to 8.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Functional subscale of WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a standardized questionnaires to evaluate the condition of subjects with knee OA in terms of pain, stiffness, and physical functioning of the joints. It contains 17 items for functional limitation, and the total functional score is ranging from 0 to 68.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Visual Analogue Scale (VAS) for pain
Visual analog scale (VAS) is a scale of 100 mm in length to measure subject's pain intensity.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Objective knee score of Knee Society Knee Scoring System (KSS)
The Knee Society Knee Scoring System (KSS) is a system that combines both objective physician-derived and subjective patient-derived component to evaluates OA knee. Five components are included: (1) patient demographics, (2) objective knee score, (3) patient expectation, (4) patient satisfaction, and (5) functional knee score. The objective knee score of KSS includes surgeon part with maximum 75 points and patient self-evaluation part with maximum 25 points.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Functional knee score of Knee Society Knee Scoring System (KSS)
The Knee Society Knee Scoring System (KSS) is a system that combines both objective physician-derived and subjective patient-derived component to evaluates OA knee. Five components are included: (1) patient demographics, (2) objective knee score, (3) patient expectation, (4) patient satisfaction, and (5) functional knee score. The total score of functional knee score ranging from 0 to 100.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Total score of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee injury and osteoarthritis outcome score (KOOS) is a questionnaire to assess the patient's opinion about their knee and associated problems. It contains 42 questions and each question is assigned with five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). The total score of the question ranging from 0 to 168.
Measured: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Total score of Whole-Organ Magnetic Resonance Imaging Score (WORMS)
The Whole-Organ-MRI Scores (WORMS) evaluates articular cartilage lesions in 14 anatomic compartments from magnetic resonance imaging (MRI) of the knee by an independent radiologist. Each compartment is scored by 8-point scale (0, 1, 2, 2,5, 3, 4, 5 and 6) and the total score is ranging from 0 to 84.
Measured: Screening, Week 24 and Week 48
Cartilage thickness in the total femorotibial joint
The cartilage thickness will be evaluated by knee MRI
Measured: Screening, Week 24 and Week 48
Percentage of subjects using the rescue medication(s)
Rescue medication(s) is defined as acetaminophen, and/or tramadol used during the study.
Measured: Screening, through Day 1 to Week 24, through Day 1 to Week 48
Total used amount of rescue medications used
Rescue medication(s) is defined as acetaminophen, and/or tramadol used during the study.
Measured: Screening, through Day 1 to Week 24, through Day 1 to Week 48
Number of days of rescue medications consumption
Rescue medication(s) is defined as acetaminophen, and/or tramadol used during the study.
Measured: Screening, through Day 1 to Week 24, through Day 1 to Week 48
Time to the first consumption of rescue medications after treatment
Rescue medication(s) is defined as acetaminophen, and/or tramadol used during the study.
Measured: through study completion, an average of 1 year
Incidence of Adverse event (AE) and serious adverse event (SAE)
AE means any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or intervention and which does not necessarily have a causal relationship with this treatment. A SAE is an AE in the view of either the investigator or Sponsor results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or the event may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above by medical judgement.
Measured: through study completion, an average of 1 year
Incidence of AE of special interest (AESI)
AEs of special interest (AESI) includes arthralgia, injection site joint pain, injection site joint swelling, and joint swelling.
Measured: through study completion, an average of 1 year
Incidence of immediate AE
Any adverse event that happens within 30 minutes post-administration of ELIXCYTE or placebo will be considered as an immediate adverse event.
Measured: Day 1
Number of subjects with abnormal vital signs
Vital signs measurement will consist of respiratory rate, pulse rate, systolic/diastolic blood pressure, and body temperature.
Measured: Screening Visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Number of subjects with abnormal findings in laboratory tests
The laboratory examination includes hematology, biochemistry, immunogenicity and pregnancy tests.
Measured: Screening Visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Number of subjects with abnormal findings in physical examination
The physical examination items include general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological, other body systems if applicable for describing the status of the subject's health.
Measured: Screening Visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start3 Jul 2023
- Primary completionMay 2026 (estimated)
- Study completionNov 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UnicoCell Biomed CO. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526001
- Sponsor's protocol ID
- CT22
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Parallel, Double-blinding, 2-Arm Study to Investigate the Efficacy and Safety of Intra-articular ELIXCYTE (Adipose-Derived Stem Cells) Injection Compared With Placebo in Subjects With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05526001
- Acronym / sponsor ID
- CT22
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- UnicoCell Biomed CO. LTDIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Sep 2022 (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.
This is a Phase III, double-blinded, placebo-controlled, multicenter study to investigate the efficacy and safety of a new study intervention, ELIXCYTE, compared to placebo (normal saline) in subjects with knee osteoarthritis. The primary hypothesis of the study is to demonstrate that ELIXCYTE is superior to placebo (saline) in improving knee pain on the target knee from baseline.
During the study, each participant will receive either ELIXCYTE (study intervention) or placebo (normal saline) intra-articular injection once on the target knee after eligibility criteria check. The target knee will be assessed by X-ray, MRI and subject self-evaluation knee questionnaires (WOMAC, KSS and KOOS) in the following visits. Other safety assessments, including lab test, physical examination, vital sign, medical/medication history and adverse events will also be collected throughout the study.
Detailed description
This Phase III study is a prospective, double-blind, parallel, multicenter, 2-arm study to evaluate the efficacy and safety of intra-articular ELIXCYTE injection compared to placebo in subjects with knee OA. All the subjects will be enrolled in Taiwan. Subjects aged 40 to 80 years with knee OA will be enrolled in the study. Approximately 165 eligible subjects will be randomized to receive either ELIXCYTE, or placebo in a 2:1 ratio.
The target population will be composed of subjects with unilateral or bilateral knee OA. For subjects with bilateral OA knees, only the knee with more severe symptoms will be selected as the target knee, while the non-target knee can continue the regular local treatment for ethical consideration. If the severities of the OA symptoms will be the same for both knees, the knee with more pain should be selected based on the WOMAC pain score. Eligible subjects will be randomized into one of the study groups (ELIXCYTE, or placebo in a 2:1 ratio).
The study consists of 9 visits and the duration per subject will be approximately 50 weeks (14 days of screening period, a treatment visit on Day 1, and 48 weeks of evaluation period). Unscheduled visit(s) may be arranged when deem necessary by the investigator.
In addition, if ELIXCYTE provided medical benefits with no safety issues to ELIXCYTE group at the end of week 48, subjects assigned to placebo group will be offered a treatment with ELIXCYTE under an extension study after study unblinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELIXCYTE | Experimental | Biological: ELIXCYTESubjects will be intra-articular (IA) injected with 4 mL of ELIXCYTE (containing 32×10^6 ADSCs) at the target knee once |
| Placebo control (Saline) | Placebo comparator | Drug: SalineSubjects will be intra-articular (IA) injected with 4 mL of saline at the target knee once |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Either gender, aged 40 to 80
- With unilateral/bilateral knee OA of Kellgren-Lawrence grading II-III (determined by American College of Rheumatology criteria of knee OA).
- WOMAC pain score of 7 - 17 in the target knee even if treated with chronic doses of NSAID.
- Has received 1 - 3 types of pharmacological therapies for knee OA for more than 3 months but the symptoms have not relieved.
- Unwilling or not suitable to undergo knee surgery (including total knee replacement and knee arthroplasty).
Key exclusion criteria (33 listed)
- Any subject meeting any of the exclusion criteria will be excluded from study participation.
- With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction (with the exception of meniscal debridement), and knee arthroplasty on the target knee joint.
- With any IA intervention of the target knee within 3 months prior to screening (e.g. steroid, anesthetic), or sodium hyaluronate by IA intervention of the target knee within 6 months prior to screening.
- Administered systemic immunosuppressive agent, systemic antiinflammatory drug, systemic steroid, systemic analgesics (except acetaminophen, and tramadol as rescue medications), duloxetine, or over-the-counter medications contain analgesics (e.g. cold medicine) within 2 weeks prior to screening. Administered systemic herbal, homeopathic, or naturopathic remedies for knee OA within 2 weeks prior to screening. A subject requiring routine use of low-dose Aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded from this study
- Administered local immunosuppressive agent, local anti-inflammatory drug, local steroid, local analgesics, over-the-counter medications contain analgesics, herbal, homeopathic, or naturopathic remedies for knee OA within 2 weeks prior to screening.
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 |
|---|---|---|
| ELIXCYTEELIXCYTE, a new investigational product developed by UnicoCell Biomed, contains allogenic Adipose-derived stem cells (ADSCs). The ADSCs of ELIXCYTE for subjects were obtained from donors, and the Sponsor followed the manufacturing and testing procedures described in chemistry, manufacturing and control (CMC) information in order to assure the quality of final products. | Biological | ELIXCYTE |
| SalinePlacebo control used in the study. | Drug | Placebo control (Saline) |
Primary outcome
Change of WOMAC pain score on the target knee
Time frame: Baseline, Week 24
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a questionnaire to evaluate the condition of subjects with knee OA. The pain score ranges from 0 to 20.
21 secondary outcomes
Percentage of pain responders (WOMAC pain score)
Time frame: Week 24 and Week 48
Total scores of WOMAC
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Pain subscale of WOMAC
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Stiffness subscale of WOMAC
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Functional subscale of WOMAC
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Visual Analogue Scale (VAS) for pain
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Objective knee score of Knee Society Knee Scoring System (KSS)
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Functional knee score of Knee Society Knee Scoring System (KSS)
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Total score of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Screening visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Total score of Whole-Organ Magnetic Resonance Imaging Score (WORMS)
Time frame: Screening, Week 24 and Week 48
Cartilage thickness in the total femorotibial joint
Time frame: Screening, Week 24 and Week 48
Percentage of subjects using the rescue medication(s)
Time frame: Screening, through Day 1 to Week 24, through Day 1 to Week 48
Total used amount of rescue medications used
Time frame: Screening, through Day 1 to Week 24, through Day 1 to Week 48
Number of days of rescue medications consumption
Time frame: Screening, through Day 1 to Week 24, through Day 1 to Week 48
Time to the first consumption of rescue medications after treatment
Time frame: through study completion, an average of 1 year
Incidence of Adverse event (AE) and serious adverse event (SAE)
Time frame: through study completion, an average of 1 year
Incidence of AE of special interest (AESI)
Time frame: through study completion, an average of 1 year
Incidence of immediate AE
Time frame: Day 1
Number of subjects with abnormal vital signs
Time frame: Screening Visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Number of subjects with abnormal findings in laboratory tests
Time frame: Screening Visit, Day 1, Week 2, 4, 12, 24, 36 and 48
Number of subjects with abnormal findings in physical examination
Time frame: Screening Visit, Day 1, Week 2, 4, 12, 24, 36 and 48
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 21 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ELIXCYTE and Saline in people with Knee Osteoarthritis, run by UnicoCell Biomed CO. LTD at 4 sites 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 13 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of WOMAC pain score on the target knee (time frame: Baseline, Week 24). 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 21 Nov 2025.