The Safety and Efficacy of XytriX (Umbilical Cord-Derived Mesenchymal Stem Cells) in the Treatment of Knee Osteoarthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Biological: Mesenchymal Stem Cell Injection

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kathryn Dziedzic, MD; Phone Number: 855-874-2359; Email: kathryn@tricelx.com

Study Locations

• United States
  • Texas
    • Frisco, Texas, United States, 75034
      • TriCelX
      • Contact: Kathryn Dziedzic; Phone Number: 855-874-2359; Email: kathryn@tricelx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

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.

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XytriX 30 million cells intra-articular injection; Subjects in this arm are receiving the drug at a 30 million cells IA dose.	Biological: Mesenchymal Stem Cell Injection; Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue
Experimental: XytriX 10 million cells IA Injection	Biological: Mesenchymal Stem Cell Injection; Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue
Experimental: XytriX 50 million cells IA dose	Biological: Mesenchymal Stem Cell Injection; Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score	Scores are transformed into a 0-100 point scale. 0 means extreme problems and 100 means no problems.	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	24 months

Collaborators and Investigators

• Sponsor: TricelX Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Knee pain; Stem Cell
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No