Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06123689
Status:
WITHDRAWN
Last Update Posted:
2024-02-28
First Post:
2023-10-27
Brief Title:
Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis OA
Sponsor:
Human Brain Wave Srl
Organization:
Human Brain Wave Srl
Study Overview
Official Title:
A Prospective Randomized Clinical Trial to Evaluate the Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis OA
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 theyll 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
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
Detailed 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 -15-2ml 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 HyaluronateHyalubrix 60 -15-2ml vial
Patients in both treatment arms will be provided with paracetamol 500 mgtablet as rescue medication for relieving knees 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
The patients will be randomized as
Group Arm 1 AMT-RegeneraActiva
Group Arm 2 Sodium HyaluronateHyalubrix 60 -15-2ml vial
Patients in both treatment arms will be provided with paracetamol 500 mgtablet as rescue medication for relieving knees 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None