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

NCT06123689 | Withdrawn

• 1 other identifier: RE78.22.01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. 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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoartrithis; knee chondropathy

Outcome Measures

Primary Outcomes (1)

• 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

  6 months overall

Secondary Outcomes (1)

• IKDC improvement

  6 months overall

Study Arms (2)

AMT-Regenera activa

EXPERIMENTAL

All the patients of the group will be treated with one unique articular injection of autologous micrografts obtained through the Rigenera® Technology

Device: AMT-Regenera activa

Hyalubrix

ACTIVE COMPARATOR

All the patients of the group will be treated with one unique articular injection of Sodium Hyaluronate (Hyalubrix 60 -1,5%-2ml vial)

Device: Hyalubrix

Interventions

AMT-Regenera activa DEVICE

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.

AMT-Regenera activa

Hyalubrix DEVICE

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

Hyalubrix

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 25-65 inclusive with open physis confirmed by MRI (Size of the articular cartilage lesion is ≥ 2 cm2)
• 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.
• Joint pain: 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
• The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
• Body Mass Index (BMI) ≤ 30 kg/m2 (extremely obese)
• No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
• 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
• Patients will have signed a consent informed

You may not qualify if:

• Patients with polyarticular disease (not applicable to polyarticular disease of the knees as the most symptomatic knee will qualify for the study)
• Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL).
• Patients who had intra-articular treatment with steroids within 3 months
• Patients who are pregnant or nursing at the time of consent.
• Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
• Patients who had previous knee surgery
• Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
• Chronic use of NSAID (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs
• Treatment with NSAIDs within 15 days prior to randomization in this study
• Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects.
• Patients with acute or chronic renal failure
• Patients who received a MRI diagnosis of OCD but do not have the specific cartilage imaging sequences.
• Clinical or laboratory evidence of septicemia
• Any problems in the ear tissue affecting the collection of cartilage

Sponsors & Collaborators

• Human Brain Wave S.r.l.: lead
• Nextrasearch S.r.l.s.: collaborator
• Ibismed S.r.l.: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Vincenzo Salini, Prof. MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

• Carlo Fiorentini, Prof. MD

  Policlinico San Donato Milanese

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 9, 2023
• Study Start: March 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 15, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: from within 6 months from the end, no limits of visibility