Osteoarthritis of the knee
Conditions
Interventions
IK-01 is transplanted or Hyaluronic acid is administered in patients with knee osteoarthritis
Sponsors
Nagashima Takafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have provided written informed consent using an IRB-approved explanation/consent form - Patients aged 20 to less than 75 years at the time of informed consent - Patients diagnosed with knee osteoarthritis according to the ACR classification criteria for knee osteoarthritis (clinical findings and X-ray imaging findings) during the screening period - Patients diagnosed with knee osteoarthritis of Kellgren-Lawrence grade 2 or 3 on standing frontal X-ray findings during the screening period
Exclusion criteria
Exclusion criteria: - Patients with a history of or need to undergo surgery such as knee meniscectomy or suturing at the time of informed consent. However, if there is a history of meniscal resection or suturing, patients who have passed 8 weeks or more after surgery can be enrolled - Patients with a history of or need surgery such as ligament reconstruction for ligament damage of the evaluation target knee at the time of informed consent. However, patients who have passed 8 weeks or more after surgery can be enrolled - Patients who are judged to be inappropriate by the principal investigator or sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the WOMAC total score at 52 weeks post-transplantation of IK-01 or post-treatment of Hyaluronic acid | — |
Secondary
| Measure | Time frame |
|---|---|
| Lysholm score, Pain VAS score and so on | — |
Contacts
Public ContactRegenerative medicine Products Development
CynosBio, Inc.
Outcome results
None listed