OsteoarthritisPhase 1/2NCT07487766
The Safety and Efficacy of XytriX (Umbilical Cord-Derived Mesenchymal Stem Cells) in the Treatment of Knee Osteoarthritis
A Phase 1/2 study testing Mesenchymal Stem Cell Injection in people with Osteoarthritis, run by TricelX Inc. at 1 site in United States.
Trial summary
This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Mesenchymal Stem Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Dec 2028
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for enrollment:
- Adult patient aged 18 years or older with Grade I-IV knee osteoarthritis as determined by radiographic (X-ray) evaluation.
- Ambulatory subject with symptoms of knee osteoarthritis for at least 3 months, who may be receiving conservative therapy (e.g., oral anti-inflammatory medication) and/or physical therapy. In subjects with bilateral knee OA, the more symptomatic knee will be designated as the target knee.
- Subject with joint pain equal to or greater than 7 (out of a total pain score of 24 points) on the target knee as assessed by the WOMAC pain subscale.
- Subject or legal representative is willing and able to provide written informed consent after reading the informed consent form (ICF) and having the opportunity to discuss the study with the investigator or designee.
- Women of childbearing potential must have a negative urine pregnancy test prior to treatment administration. Women of childbearing potential and males who are heterosexually active with a female of childbearing potential must agree to use a double barrier method of contraception for at least 4 weeks following administration, unless the female partner is post-menopausal (defined as 12 months of spontaneous amenorrhea, or 6 months amenorrhea with FSH >40 mIU/mL) or has undergone surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from participation:
- Suspected or confirmed pregnancy, or planning to become pregnant within 2 years of treatment.
- Body mass index (BMI) over 40 kg/m². Knee deformity (varus or valgus greater than 10 degrees) on the target knee. Acute inflammation, tense effusion (e.g., infection), or active bleeding on the target knee as judged by the Principal Investigator (PI).
- Ligament instability (cruciate or collateral ligaments) or ligament laxity of the target knee as judged by the PI.
- History of surgery, articular injury, ligament reconstruction, or meniscus repair on the target knee within the previous 6 months.
- History of arthroscopic surgery in the target knee in the past 6 months, or planned arthroscopy or knee replacement during the trial period.
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- History of total knee replacement procedure on the target knee. Intra-articular injection of any treatment (hyaluronic acid, corticosteroids, or platelet-rich plasma [PRP]) on the target knee in the last 3 months prior to enrollment.
- Known history of osteoarthritis of the hip or ankle. Known history of any systemic autoimmune rheumatic disease, including but not limited to: rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease (IBD), sarcoidosis, lymphoma, or amyloidosis.
- Active malignancy or treatment for cancer within the past year. Active systemic infection. Known HIV infection. Active hepatitis B or active hepatitis C. Immunocompromised state. Significant concomitant illness as judged by the PI. Hemodynamic instability. Chronic multi-system organ failure. Organ transplant history. Known allergy or hypersensitivity to any component of the investigational product, including DMSO, cell therapies, or hyaluronic acid. Subjects with known sulfur hypersensitivity are specifically excluded due to the DMSO in the cryoprotectant.
- Known allergy or hypersensitivity to any concomitant or rescue medications. Significant skin disease at the injection site on the target knee as judged by the PI.
- Participation in another clinical trial or treatment (immunosuppressant therapies, systemic steroids, cytotoxic drugs, chemotherapy, radiation therapy, new investigational drugs or cell therapy) within 3 months prior to enrollment.
- Inability to provide informed consent or to have a legal representative provide informed consent.
- Medical condition that would, in the opinion of the investigator, compromise the patient's safety or ability to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
TriCelX
Frisco, Texas, 75034
Kathryn Dziedzic, 855-874-2359, kathryn@tricelx.com
About this study
Official title: A Phase 1/2, Single-Blinded Trial to Evaluate the Safety and Efficacy of Intra-Articular (IA) Injection of XytriX in Adult Subjects With Grade I-IV Knee Osteoarthritis (KOA)
This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Mesenchymal Stem Cell Injection
- Keywords
- Knee pain, Stem Cell, Osteoarthritis, Arthritis
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell InjectionBiological
Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue
| Study group | Role | What they receive |
|---|---|---|
| XytriX 30 million cells intra-articular injection | Experimental | Subjects in this arm are receiving the drug at a 30 million cells IA dose. Receives: Biological: Mesenchymal Stem Cell Injection |
| XytriX 10 million cells IA Injection | Experimental | Not described Receives: Biological: Mesenchymal Stem Cell Injection |
| XytriX 50 million cells IA dose | Experimental | Not described Receives: Biological: Mesenchymal Stem Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score
Scores are transformed into a 0-100 point scale. 0 means extreme problems and 100 means no problems.
Measured: 24 months
Western Ontario and McMaster Universities Osteoarthritis Index
Items are typically scored on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Lower scores indicate better outcomes, while higher scores indicate worse pain, stiffness, and functional limitations.
Measured: 24 months
Secondary outcomes (4)
Visual Analog Pain Score
The Visual Analog Scale (VAS) is a 100mm horizontal line anchored by "no pain" (0mm) and "worst pain imaginable" (100mm) used to measure pain intensity. Patients mark the line, and the distance in millimeters provides a 0-100 score.
Measured: 24 months
KOOS Sub-Scale
Change from baseline in all KOOS subscales (pain, symptoms, activities of daily living, sport and recreation, quality of life).
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item, self-administered questionnaire assessing five distinct subscales for knee health: Pain, Symptoms, Daily Living Activities (ADL), Sport/Recreation, and Quality of Life. It ranges from 0 (worst) to 100 (best) and is used to measure short- and long-term consequences of knee injury
Measured: 24 months
Short Form-36 (SF-36)
This is a widely used, patient-reported survey measuring health-related quality of life across eight domains, including physical, emotional, and social functioning. It consists of 36 items, typically assessing the past four weeks, used to calculate physical (PCS) and mental (MCS) health summary scores ranging from 0 to 100. Items are transformed into a 0-100 scale, where higher scores represent better health.
Measured: 24 months
Timed Up and Go Test
The Timed Up and Go (TUG) test is a simple, quick assessment used to measure an individual's balance, functional mobility, and fall risk. It requires the person to rise from a chair, walk 3 meters (10 feet), turn around, walk back, and sit down. A result of under 10-12 seconds is typically considered normal, while longer times indicate increasing fall risk.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Patients will be randomized into one of three dosage groups (10 million cells, 30 million cells, and 50 million cells).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TricelX Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487766
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Single-Blinded Trial to Evaluate the Safety and Efficacy of Intra-Articular (IA) Injection of XytriX in Adult Subjects With Grade I-IV Knee Osteoarthritis (KOA)
- ClinicalTrials.gov ID
- NCT07487766
- Acronym / sponsor ID
- 1
- Conditions
- Osteoarthritis
- Keywords
- Knee pain, Stem Cell, Osteoarthritis, Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- TricelX Inc.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Mar 2026 (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 study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients will be randomized into one of three dosage groups (10 million cells, 30 million cells, and 50 million cells).
| Arm | Type | Receives |
|---|---|---|
| XytriX 30 million cells intra-articular injection | Experimental | Biological: Mesenchymal Stem Cell InjectionSubjects in this arm are receiving the drug at a 30 million cells IA dose. |
| XytriX 10 million cells IA Injection | Experimental | Biological: Mesenchymal Stem Cell Injection |
| XytriX 50 million cells IA dose | Experimental | Biological: Mesenchymal Stem Cell Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient aged 18 years or older with Grade I-IV knee osteoarthritis as determined by radiographic (X-ray) evaluation.
- Ambulatory subject with symptoms of knee osteoarthritis for at least 3 months, who may be receiving conservative therapy (e.g., oral anti-inflammatory medication) and/or physical therapy. In subjects with bilateral knee OA, the more symptomatic knee will be designated as the target knee.
- Subject with joint pain equal to or greater than 7 (out of a total pain score of 24 points) on the target knee as assessed by the WOMAC pain subscale.
- Subject or legal representative is willing and able to provide written informed consent after reading the informed consent form (ICF) and having the opportunity to discuss the study with the investigator or designee.
- Women of childbearing potential must have a negative urine pregnancy test prior to treatment administration. Women of childbearing potential and males who are heterosexually active with a female of childbearing potential must agree to use a double barrier method of contraception for at least 4 weeks following administration, unless the female partner is post-menopausal (defined as 12 months of spontaneous amenorrhea, or 6 months amenorrhea with FSH >40 mIU/mL) or has undergone surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.
Key exclusion criteria (13 listed)
- Suspected or confirmed pregnancy, or planning to become pregnant within 2 years of treatment.
- Body mass index (BMI) over 40 kg/m². Knee deformity (varus or valgus greater than 10 degrees) on the target knee. Acute inflammation, tense effusion (e.g., infection), or active bleeding on the target knee as judged by the Principal Investigator (PI).
- Ligament instability (cruciate or collateral ligaments) or ligament laxity of the target knee as judged by the PI.
- History of surgery, articular injury, ligament reconstruction, or meniscus repair on the target knee within the previous 6 months.
- History of arthroscopic surgery in the target knee in the past 6 months, or planned arthroscopy or knee replacement during the trial period.
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 |
|---|---|---|
| Mesenchymal Stem Cell InjectionSubjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue | Biological | XytriX 10 million cells IA Injection, XytriX 30 million cells intra-articular injection, XytriX 50 million cells IA dose |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score
Time frame: 24 months
Scores are transformed into a 0-100 point scale. 0 means extreme problems and 100 means no problems.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 24 months
Items are typically scored on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Lower scores indicate better outcomes, while higher scores indicate worse pain, stiffness, and functional limitations.
4 secondary outcomes
Visual Analog Pain Score
Time frame: 24 months
KOOS Sub-Scale
Time frame: 24 months
Short Form-36 (SF-36)
Time frame: 24 months
Timed Up and Go Test
Time frame: 24 months
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stem Cell Injection in people with Osteoarthritis, run by TricelX Inc. at 1 site in United States.
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 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. 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 United States. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Dziedzic, MD (855-874-2359, kathryn@tricelx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.