Safety and efficacy evaluation of intra-articular knee transplantation of three consecutive doses of Platelet-Rich Plasma in patients with knee osteoarthritis: Interventional clinical trial, Phase II

Determining the safety of intra-articular injection of three consecutive doses of platelet-rich plasma derived from non-autologous umbilical cord blood in patients with knee osteoarthritis

Randomised controlled trial, with parallel groups, double-blind, phase 1/2 on 30 patients, randomized using Random allocation software

Patients are injected 3 times at 0-, 1-, and 2-month intervals in the operating room at Royan Clinic. Patients will be monitored for up to one year. For the purpose of blinding, the biological product will be prepared in the form of disposable 5 cc syringes that look exactly like each other with a special label. Only the doctor and the person in charge of the transplant will know the type of treatment received.

Inclusion criteria: age range 45-70, years of knee osteoarthritis with grade 2 and 3 MRI diagnosis, knee pain ≥4, completion of informed consent form Exclusion criteria: pregnant, lactating women or disabled adults, intrachondral injection within the last 2 months, Abnormal hematological or biochemical tests, History of any type of neoplasm, Aspirin consumption one week before cell injection, History of coagulopathy or use of anticoagulant drugs, Positive viral tests, Rheumatoid arthritis or other autoimmune diseases involving joints, History of corticosteroid use in 3 last month

Control group: patients receiving 3 doses of hyaluronic acid; Test group: patients receiving 3 doses of PRP.

Adverse events (AEs) and severe adverse events (SAEs), WOMAC, VAS, SF-36, Articular cartilage thickness

This update is being made to correct administrative data-entry errors in the trial registration. During registration, some information from a separate but similar MSC study was inadvertently entered into the record of this PRP study. Specifically, the investigational product was incorrectly described as MSCs in one section, whereas the correct intervention is platelet-rich plasma (PRP). In addition, the injection interval was incorrectly recorded as every two months, whereas the ethics-approved PRP protocol specifies one injection per month. These corrections do not represent changes to the approved protocol. The ethics-approved protocol has consistently specified PRP as the intervention and monthly administration as the treatment schedule. The registry is being updated solely to ensure that the registered information accurately corresponds to the protocol approved by the Research Ethics Committee.

Patients will be randomly assigned to the control and PRP groups. The method of random assignment of these two groups is block randomization. The size of the blocks is 6 people, and using Random allocation software, the sequence of assigning patients to the groups is determined, and this sequence will be kept by the transplant manager.

This study is a double-blind study. Patients and study analysts will be unaware of the type of treatment assigned. To achieve this goal, by using a biological product in the form of disposable 5 cc syringes that are already filled by the nurse and are completely "similar" to the type of treatment received, to blind the participants in the study. Also, the people who apply the treatment will be different from the people who are responsible for examining and evaluating the patients, and the biological product packages will be labeled according to a specific code. Only the doctor and the person in charge of the transplant will know the type of treatment the patients receive.

The information and data will be published as an article after reviewing and verifying them. All data is potentially shareable after unidentified individuals.

After following the patients and collecting data, checking the safety and efficiency of cell injection and then writing the article, which is done about 3 months after the follow-up, the data file will be published.

Access to the documents of this research is not limited to academic and scientific researchers, and specialists working in other centers can also access these documents.

Designing similar studies in other academic centers

e.afzal@rsct.it

Within 1-2 months after application. Applicants for access to the research documents must provide evidence of their activity in the relevant field and their need for this data along with their application email.