Physician-initiated clinical trial to evaluate the efficacy of intra-articular injection of platelet-rich plasma (PRP) for knee osteoarthritis: a multicenter, randomized, double-blind, comparative study

JRCT ID: jRCT2032220677

Registered date:03/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis of the Knee
• Date of first enrollment: 05/07/2023
• Target sample size: 116
• Study type: Interventional
• Intervention(s): Using the study device JC 5724, 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 prepared from approximately 70 mL of subject's own peripheral blood. A single dose of approximately 6 mL of prepared PRP or the same amount of placebo solution is administered into the joint cavity of the index knee.

Outcome(s)

• Primary Outcome: Change from baseline in JKOOS Pain Subscale at 6 months after study treatment (with missing values supplemented by LOCF)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Select subjects who satisfy all of the following items at the time of enrollment.
1. Written informed consent has been obtained from the patient himself/herself.
2. Male or female aged more than 20 years and less than 80 years at screening.
3. Willingness and ability to comply with study procedures and visitation schedules.
4. Ability to follow oral and written instructions.
5.Patients who have knee pain in the index knee, osteophytes on standing radiographs, and who meet at least one of his three criteria below
(1) Age 50 or older (2) Stiffness less than 30 minutes (3) Crepitus during knee movement
6. Upright knee radiograph Kellgren-Lawrence grade 2-3 and no severe osteoarthritis
7. Meet BMI 35 or less
8. Satisfying VAS Pain 4 or more at the index knee joint at the time of informed consent and at Visit 1
9. JKOOS pain subscale 60 or less at the index knee joint at the time of informed consent and at Visit 1
10. Patients who have received conservative treatment for osteoarthritis of the knee for 6 months or more before obtaining informed consent, and whose medical history indicates that the treatment is inadequate or difficult to continue due to safety reasons. and what can be confirmed by interview. If the clinical trial medical institution does not have source materials to confirm the medical history due to a referral from another hospital, the investigator, etc. will contact the referral medical institution and retain the original data in the form of providing medical information. If confirmation is made by telephone or other means, record the confirmation destination, confirmation date, and confirmation details in the chart. The investigator etc. will make the final judgment as to whether or not it is difficult to continue treatment.
Insufficient effect: administration of NSAIDs or acetaminophen for 4 weeks (28 days) or more 28 days) or more) and when subjective symptoms do not improve despite administration of hyaluronic acid for 3 or more times.
Among these patients, those who seemed to require administration of weak opioids or SNRIs for severe pain showed improvement in subjective symptoms despite the administration of weak opioids or SNRIs for 13 weeks (91 days) or more. is not permitted.
Difficulty in continuing treatment: Due to side effects, when the doctor judges that it is not possible to continue administration of the above NSAIDs, acetaminophen, hyaluronic acid, weak opioids, and SNRIs from the viewpoint of safety.
11. Consent to participate in ancillary research
12. Appropriate contraception is possible from the time consent is obtained until the end of the observation period after 6 months of study treatment. Use appropriate contraceptives with oral contraceptives (pills), condoms, vasectomy, tubal ligation, contraceptive diaphragms, intrauterine devices, or spermicides)
13. Subjects who are in good health and are considered to be able to collect about 70 mL of blood for PRP preparation

Exclude criteria

Exclude any of the following at the time of registration:
1. Existence of knee osteoarthritis satisfying VAS Pain more than 4 in the knee joint not subject to the study
2. Rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, secondary knee arthritis due to other inflammatory diseases, HIV, viral hepatitis, chondrocalcinosis, Paget's disease, pigmented villous nodules Having a diagnosis of synovitis or knee intra-articular hematoma
3. Subjects judged by the investigator to have psychogenic pain in the index knee
4. If you have a feeling of being caught in the knee (a symptom in which the knee joint does not bend and stretch smoothly), or a feeling of instability in the knee (a symptom in which the knee lacks stability during daily life or exercise)
5. If the joint line convergence angle (JLCA) of X-ray photograph at knee standing load is 4 degrees or higher
6. On MRI images, coexistence of ligament damage, meniscal tear such as medial meniscal posterior root tear (however, meniscal damage without tear is not excluded), or coexistence of idiopathic osteonecrosis of the knee. If confirmed in the knee
7. Presence of clinically observable active infection in the index knee
8. Have an untreated symptomatic injury to the index knee
9. Presence of surgical instruments or other foreign bodies intended to treat arthritic or cartilage-related lesions in the index knee
10. History of cartilage repair surgery on the damaged cartilage surface of the index knee
11. If you plan to have surgery on the index knee during the study participation period
12. If there is a skin lesion on the index knee
13. Previous intra-articular administration of PRP in the index knee
14. Complications of psychiatric disease or psychiatric symptoms that make it difficult to participate in clinical trials
15. When there is a problem in filling in the evaluation index
16. Patients who received intra-articular injections other than hyaluronic acid (adrenal cortical hormones (steroids), etc.) into the index knee within 12 weeks (84 days) before obtaining consent
17. If you are using or plan to use anticancer drugs
18. Using biologics or immunosuppressants
19. Diagnosed with leukemia or known to have malignancy
20. If the test for infectious diseases (HBV, HCV, HIV, syphilis) is determined to be positive (test items and positive/negative judgments are based on the usual clinical practice of each clinical trial medical institution)
21. Grade 3 serious complications (cardiac disease, If you have lung disease, liver disease, renal disease, bleeding tendency, uncontrolled diabetes, hypertension, etc.)
22. Women who are pregnant, breastfeeding, or planning to become pregnant during study participation
23. Subjects who have participated in clinical trials of unapproved drugs, medical devices, regenerative medicine products, etc. within 6 months before screening
24. Persons who are judged inappropriate for participation in this clinical trial by the principal investigator, etc.

Related Information

• Primary Sponsor: Sato Masato
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development