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

Human Brain Wave S.r.l.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Knee Osteoarthritis

Interventions

AMT-Regenera activaDEVICE

Patient's preparation: is an ambulatory procedure, the sterility of the Micrograft and the method should be guaranteed during the whole procedure. Punch biopsy extraction: The punch should be obtained by the posterior auricular shell area. The zone cleaned with antiseptic solution. Anesthesia is applied in the posterior zone in the base area of the auricular shell. It should be applied superficially to separate the skin from the cartilage . Should be obtained by 3 dermic punches of 2,5mm diameter. The skin is separated from the perichondrium and cartilage. 1. Once the samples are obtained, they must be put on the metallic grid of the Rigeneracon 2. Afterwards, 4 ml of Saline solution are added in the inferior part of the Rigeneracon, then close the lid and then put it in the machine with the needed adaptors. 3. The samples are processed for 6 minutes 4. The Rigeneracon is extracted from the machine.

HyalubrixDEVICE

Patients randomized in Group 2 Sodim Hyaluronate (Hyalubrix 60 -1,5%-2ml vial). NOTE: For the infiltration in the medial knee compartment treatment, the use of intramuscular needle is recommended. The care post-treatment The homeostasis of the donor's area is achieved by mechanical compression. Usually, there is no need of stitches. Often it can be seen a bit of inflammation during the first 24-72 hours. The use of analgesic drugs is recommended, avoiding the NSAID, they can interfere in the function of micrografts. Apply intermittently cold on the area or a compressive bandage, if needed

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female age 25-65 inclusive with open physis confirmed by MRI (Size of the articular cartilage lesion is ≥ 2 cm2) 2. Documented symptomatic stable diagnosed degenerative knee chondropathy from grade II to III based on MRI without changes of osteoarthritis and no prior history of knee surgery. The MRI diagnosis must be within a 3-month time period prior to consent. 3. Joint pain: 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening 4. The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal. 5. Body Mass Index (BMI) ≤ 30 kg/m2 (extremely obese) 6. No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining 7. Patient has complied with the requirements for rescue medication (no more than 4 tablets or 2 grams of paracetamol per day up to 4 days per week 8. Patients will have signed a consent informed Exclusion Criteria: 1. Patients with polyarticular disease (not applicable to polyarticular disease of the knees as the most symptomatic knee will qualify for the study) 2. Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL). 3. Patients who had intra-articular treatment with steroids within 3 months 4. Patients who are pregnant or nursing at the time of consent. 5. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis) 6. Patients who had previous knee surgery 7. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments. 8. Chronic use of NSAID (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs 9. Treatment with NSAIDs within 15 days prior to randomization in this study 10. Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects. 11. Patients with acute or chronic renal failure 12. Patients who received a MRI diagnosis of OCD but do not have the specific cartilage imaging sequences. 13. Clinical or laboratory evidence of septicemia 14. Any problems in the ear tissue affecting the collection of cartilage

Outcomes

Primary Outcomes

AMT Regenera improvement of pain management

To demonstrate that AMT-RegeneraActiva is able to speed up the change process of knee osteoarthritis (OA) compared to Sodium Hyaluronate (Hyalubrix 60 -1,5%-2ml vial) to pain management and consequent change of functionality in patients with knee OA (grade II-III Kellgren-Lawrence grading scale) from baseline after unique administration of ATM Regenera-Activa treatment by interarticular injection. KOOS score will be tool to measurement of this change

Time frame: 6 months overall

Secondary Outcomes

IKDC improvement

IKDC patient reported SCORE

Time frame: 6 months overall

Data from ClinicalTrials.gov

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