Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)

Knee Osteoarthritis Clinical Trial

Official title: A Prospective, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to compare in 60 patients suffering for Knee OA to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compared to Sodium Hyaluronate Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].

Researchers will compare 2 Groups to see to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compared to Sodium Hyaluronate to pain management and improvement of functionality.

Clinical Trial Description

All the patients participating in the study will have had been diagnosed with degenerative knee chondropathy from grade II to III of Kellgren-Lawrence grading scale and they will have signed a consent informed. The age rate established is from 25 to 65 years old. All the patients, except control group, will be treated with one unique articular injection of autologous micrografts obtained through the Rigenera® Technology. The control group will receive Sodium Hyaluronate (Hyalubrix 60 -1,5%-2ml vial). To assess the level of satisfaction of the patient, the reduction of pain, and the functional state of the articulation, Knee Osteoarthritis Outcome Score (KOOS) will be used, before the treatment, 3 months after the treatment, and at 6 months after the treatment.

The patients will be randomized as:

• Group (Arm) 1: AMT-RegeneraActiva

• Group (Arm) 2: Sodium Hyaluronate(Hyalubrix 60 -1,5%-2ml vial).

Patients in both treatment arms will be provided with paracetamol (500 mg/tablet) as rescue medication for relieving knee's pain. This will be taken as needed for pain with a maximum of 4 tablets or 2 grams of paracetamol per day up to 4 days per week.

If more rescue medication is needed for pain, (recorded as the 'Number of Rescue Medication Taken for pain' in the daily diary) the patient will be considered a treatment failure. Patients deemed treatment failures for rescue medication use will continue to participate in follow-up visits for safety.

During the study patients in both arms must report in a daily paper diary consumption of rescue medication, in particular, the following information will be collected:

Rescue paracetamol for OA:

• Amount of rescue medication taken for OA in the past 24 hours.

• Any non-rescue pain medication for OA or for pain other than OA

The consumption of rescue medication will be checked from the Investigators will be carefully documented at all visits during the study. ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT06123689
• Study type: Interventional
• Source: Human Brain Wave S.r.l.
• Contact: Adolfo Gasparetto, MD
• Phone: +39 3356641965
• Email: adolfogasparetto@nextrasearch.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Completion date: September 2024