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

NCT06123689 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-03

No results posted yet for this study

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

Interventions

DEVICE

AMT-Regenera activa

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.

DEVICE

Hyalubrix

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

Sponsors & Collaborators

  • Nextrasearch S.r.l.s.

    collaborator OTHER

  • Ibismed S.r.l.

    collaborator UNKNOWN

  • Human Brain Wave S.r.l.

    lead INDUSTRY

Principal Investigators

  • Vincenzo Salini, Prof. MD · Ospedale San Raffaele

  • Carlo Fiorentini, Prof. MD · Policlinico San Donato Milanese

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-05-01
Completion
2024-05-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123689 on ClinicalTrials.gov