Osteoarthritis
Conditions
Interventions
Transplantation of processed autologous adipose-derived stem cells.
Sponsors
Saita Yoshitomo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men and women whose consent acquisition date is more than 18 years. 2.Patients who have pain at the target site more than 3 months before the date of consent.(Patients who have no positive effects of previous conservative treatment such as hyaluronic acid or PRP therapy.) 3.Patients diagnosed as osteoarthritis (KL grade 1 or more) by upright knee radiograph. 4. VAS 40 or higher (For patients with pain in both knees, the one with the higher VAS value will be targeted; if the VAS values are the same, ASCs are administered to 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 with locolotive syndrome, malignant tumor, contagious disease, or blood disorder. 2.Patients who have had knee surgery within the last 6 months or had intra-articular knee injections within the last 3 months. 3.Patients with psychiatric disorders or substance abuse disorders, patients who have difficulty communication, or pregnant women. 4.Patients for whom doctors decide as not appropriate to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment of regenerative medicine technology using the processed cells. If (1) or (2) of the following occurs, we will consider whether or not to enroll the subject in the study, treat the subject, or continue the study as a whole at that time. (1) Serious adverse events in the target disease which evaluated as greater than grade 3 by Japanese translation (JCOG version) of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. (2) In accordance with the Act on Ensuring the Safety of Regenerative Medicine (ASRM), in the event of "a disease, injury, death, or infectious disease suspected to be caused by the provision of regenerative medicine. described in the plan for the provision of regenerative medicine." | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Evaluation of knee joint pain by VAS. (2)Patient reported outcome (PRO). | — |
Countries
Japan
Contacts
Public ContactMiho Inada
Gaudi Clinical Inc.
Outcome results
None listed