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

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)

Overview

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.

Interventions

• Biological Mesenchymal Stem Cell Injection
  Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue

Primary outcome measures

• Knee Injury and Osteoarthritis Outcome Score [Time frame: 24 months]
• Western Ontario and McMaster Universities Osteoarthritis Index [Time frame: 24 months]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• TriCelX — Frisco

Identifiers

NCT: NCT07487766 · 1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗