A Phase 1/2 interventional study of Mesenchymal Stem Cell Injection in Osteoarthritis, sponsored by TricelX Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by TricelX Inc. · Phase 1/2, Interventional, and Treatment
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 75 is close to the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with TricelX Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 after reading the informed consent form (ICF) and having the opportunity to discuss the study with the investigator or designee.
Women of 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 for at least 4 weeks following administration, unless the female partner is (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.
Exclusion Criteria:
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.
(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.
History of total knee replacement procedure on the target knee. Intra-articular injection of any treatment (hyaluronic acid, , or -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 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 or treatment for cancer within the past year. Active systemic infection. Known infection. Active or active . state. Significant concomitant illness as judged by the PI. Hemodynamic instability. Chronic multi-system organ failure. Organ transplant history. Known allergy or to any component of the 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm are receiving the drug at a 30 million cells IA dose.
Biological: Mesenchymal Stem Cell Injection
Biological: Mesenchymal Stem Cell Injection
Biological: Mesenchymal Stem Cell Injection
Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue
Knee Injury and Osteoarthritis Outcome Score
Scores are transformed into a 0-100 point scale. 0 means extreme problems and 100 means no problems.
Time frame: 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.
Time frame: 24 months
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesenchymal Stem Cell