Evaluation of therapeutic effect of placental mesenchymal stem cell exosome injection in improving clinical symptoms and MRI changes in patients with knee osteoarthritis

Evaluation of therapeutic effect of placental mesenchymal stem cell exosome injection in improving subjective symptoms and objective imaging findings in patients with knee osteoarthritis

Clinical trial with control group, with parallel groups, triple blinded, randomized, phase 3 on 30 patients.

In this triple blinded clinical trial, patients with osteoarthritis of the knee referred Taleghani hospitals were randomly divided into two groups of 30 patients. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne Index as well as Visual Analogue Scale (VAS) are completed for patients. All patients undergo X-ray imaging and MRI of the knee. The intervention group received exosome injection and exercise therapy, and the control group received normal saline injection and exercise therapy. The mentioned questionnaires, in addition to the time before the intervention, will be completed at the end of months 2 and 6 for all patients. At the end of month 6, MRI of the knees is repeated.

Inclusion criteria: 1) pain in both knees during the last 6 months, 2) graphic confirmation of bilateral knee osteoarthritis with grade 2 or 3; Exclusion criteria: 1) younger than 45 years or older than 65 years, 2) any intra-articular injection of the knee during the last 3 months

Patients in the intervention group received 5 cc of exosome in the knee joint, and the control group received 5 cc of normal saline. Knee strengthening and stretching exercises are taught to patients in both groups.

VAS; WOMAC Index; Lequesne index; Patellofemoral cartilage volume; Tibiofemoral cartilage volume; Knee joint synovitis; Internal and external meniscus disintegration; Patellofemoral cartilage erosion; Tibiofemoral cartilage erosion; Anterior cruciate ligament injury

In this clinical trial study, 30 patients with bilateral osteoarthritis of the knee, referred to the physical medicine and rehabilitation clinic of Taleghani Hospital in Tehran, will be randomly entered into the study. Random Allocation software will be used for random assignment of samples. Random sequences from 1 to 30 will be created using this software. Random allocation concealment method will be used for hiding. In this way, the created sequences are recorded on cards and these cards will be placed in sealed envelopes. Then, according to the order of entry of eligible people to study, each envelope will be opened and their assigned number will be determined. Thus, if the desired number was even, the right knee will be selected as the intervention and the left knee as the control, and if the desired number is odd, the left knee will be selected as the intervention and the right knee as the control.

According to the codings performed for patients and drugs, all patients, caregivers, data collector, people who evaluate the outcomes, as well as data analyzer, for the intervention performed in each patient (drug or Placebo) are unaware. Both knees of the patient are injected. Drug is injected in one knee and placebo in the other, randomly.