Osteoarthritis of the Knee
Conditions
Interventions
Using the Cellaid P type kit, which is a blood component separation container used to separate plasma containing platelets, etc. from blood, approximately 6 mL of PRP (platelet-rich plasma) is prepare
Sponsors
Sato Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria at the time of enrollment will be selected: (1) The patient's free written consent has been obtained. (2) Participated in the JC-5724-01 investigator-initiated clinical trial and completed all visits as stipulated. (3) Willing and able to comply with the examination procedures and visit schedule. (4) Ability to comply with oral and written instructions (5) Those who are in good health and are considered to be able to collect approximately 70 mL of blood for PRP preparation. (6) Those who are able to use adequate contraception from the time consent is obtained until the end of the observation period of 6 months after treatment (patients of childbearing potential and male patients will use appropriate contraception using oral contraceptives (pills), condoms, vasectomy, tubal ligation, contraceptive pessary, intrauterine device or spermicide during the clinical study period (until the end of the observation period).
Exclusion criteria
Exclusion criteria: Exclude subjects who fall under any of the following at the time of enrollment: (1) Failure to complete the visit as stipulated in the JC-5724-01 investigator-initiated clinical trial (2) Presence of clinically observed active infection in the indicative knee (3) Have untreated symptomatic damage to the indicative knee (4) If you are planning to have index knee surgery during the participation period (5) When there is a skin injury on the knee that is an indicator (6) If the applicant has a mental illness or psychiatric symptoms and is deemed to be unable to participate. (7) When there is a problem in filling in the evaluation indicators (8) If you are using or planning to use anticancer drugs (9) If you are using biologics or immunosuppressive agents (10) If you have been diagnosed with leukemia or if you know that a malignant tumor exists. (11) If the test for infectious diseases (HBV, HCV, HIV, syphilis) is determined to be positive (test items and positive/negative judgment shall be in accordance with the usual medical care of each clinical trial medical institution) (12) If the patient has serious complications (heart disease, lung disease, liver disease, kidney disease, bleeding tendency, uncontrolled diabetes mellitus and hypertension, etc.) as shown in the severity classification criteria for adverse reactions of pharmaceuticals, etc. (Notice of the Director of the Safety Division of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare No. 80 on June 29, Heisei 4). (13) Women who are pregnant, breastfeeding, or planning to become pregnant during the participation period (14) Any other person who is judged by the Principal Investigator to be inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in JKOOS Pain Subscale at 6 months after treatment (with missing values supplemented by LOCF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in JKOOS Subscale at 6 months after treatment Change from baseline in VAS Pain at 6 months after treatment Change from baseline in EQ-5D-5L at 6 months after treatment OMERACT-OARSI Responder Criteria Transition of responder according to OMERACT-OARSI Responder Criteria | — |
Countries
Japan
Contacts
Public ContactRyoka Uchiyama
Tokai University
Outcome results
None listed