Knee osteoarthritis
Conditions
Interventions
Injection of autologous DFAT cells into the patient's kee joint cavity.
Sponsors
Nakanishi Kazuyoshi
Matsumoto Taro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 or older at the time of consent 2. Choronic knee pain lasting more than 3 months. (Resistant to exsisting conservative treatments including hyaluronic acid or PRP therapy) 3. Patients with knee osteoarthritis with KL grade 1 or higher on standing sinple X-ray. 4. VAS 40 or higher (For patients with pain in both knees, the one with the higher VAS values will be targeted. If the VAS value are the same, the cells are administered th the one knee determined by the doctor.) 5. Patients who have received sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in the study group based on their free will.
Exclusion criteria
Exclusion criteria: 1. Patients who have had knee surgery within the last 6 months or had intra-articular injections within last 3 months. 2. Patients with poorly controlled diabetes mellitus (HbA1C > 8.0%) 3. Patients with concomitant malignancy or a history of malignancy within 5 years prior to obtaining consent (except for appropriately treated non-melanoma skin cancer or epithelial carcinoma of the cervix). 4. Patients with positive HBs antigen, HBc antibody, HCV antibody, or syphilis serology. 5. Patients with a history of serious allergy or adverse reaction to lidocaine (e.g., Xylocaine). 6. Patients with psychiatric diorders that are difficult to control (dementia, alcoholism, etc) 7. Pregnant women, lactating women, and women who may be pregnant or plannning to become pregnant by the end of the observation period. 8. Patients who are deemed by the investigator to be unsuitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Occurrence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficasy: Percentage change from baseline in various clinical scores (VAS, KOOS, and WOMAC) at 4, 12, and 24 weeks post-transplant. | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Matsunaga
Nihon University
Outcome results
None listed