Long-term Follow-up Study of EVA-001 for Knee Osteoarthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2033260212

Enrollment

Registered

2026-06-11

Start date

2026-06-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible. Unless otherwise noted below, these criteria will be verified during the screening period (Visit 1). 1) Patients who participated in the EVA-001-02 or EVA-001-03 trial, received EVA-001, and completed their final visit, 2) Patients for whom at least 92 weeks have elapsed since the date of EVA-001 administration, 3) Patients who voluntarily decided to participate in this clinical trial and signed the informed consent form

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. 1) Patients who have undergone secondary invasive treatment since the final visit of the EVA-001-02 or EVA-001-03 trial, 2) Patients scheduled to undergo surgical treatment on the target knee, 3) Patients who have participated in clinical trials other than the EVA-001-02 and/or EVA-001-03 trials within the past 3 months, 4) Patients with a history of contraindications to magnetic resonance imaging (MRI) of cartilage or, if contrast agents are used, to contrast agents, 5) Patients deemed ineligible by the principal investigator (or sub-investigator) based on an assessment of safety and efficacy (including subjective judgment, etc.)

Design outcomes

Primary

Measure	Time frame
Change from baseline in the WOMAC Scale at 60 months post-administration	—

Secondary

Measure	Time frame
Primary secondary endpoints, 1) Change from baseline in the WOMAC Scale at 36 months post-administration, 2) Treatment Failure Rate Other secondary endpoints, 1) Change from baseline in the 100 mm VAS at 36 and 60 months after administration, 2) Change from baseline in the IKDC Score at 36 and 60 months after administration, 3) Change from baseline in each WOMAC subscale (pain, physical function, and stiffness) at 36 and 60 months after administration, 4) Change from baseline in the KOOS Scale at 36 and 60 months after administration, 5) Change from baseline in the MRI-based knee osteoarthritis score (MOAKS) at 36 and 60 months post-administration, 6) MRI assessment of cartilage repair tissue (MOCART) at each evaluation time point, 7) Health-related quality of life (EQ-5D-5L) at each assessment time point	—

Measure

Time frame

Primary secondary endpoints, 1) Change from baseline in the WOMAC Scale at 36 months post-administration, 2) Treatment Failure Rate Other secondary endpoints, 1) Change from baseline in the 100 mm VAS at 36 and 60 months after administration, 2) Change from baseline in the IKDC Score at 36 and 60 months after administration, 3) Change from baseline in each WOMAC subscale (pain, physical function, and stiffness) at 36 and 60 months after administration, 4) Change from baseline in the KOOS Scale at 36 and 60 months after administration, 5) Change from baseline in the MRI-based knee osteoarthritis score (MOAKS) at 36 and 60 months post-administration, 6) MRI assessment of cartilage repair tissue (MOCART) at each evaluation time point, 7) Health-related quality of life (EQ-5D-5L) at each assessment time point

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Contacts

Public ContactKazuhiro Yamazaki

MEDIPOST K.K.

kazuhiro.yamazaki@medi-post.co.jp+81-3-5422-6273

Outcome results