Knee OsteoarthritisNCT06123689
Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)
A study testing AMT-Regenera activa and Hyalubrix in people with Knee Osteoarthritis, run by Human Brain Wave S.r.l..
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AMT-Regenera activa and Hyalubrix
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: A Prospective, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)
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.
Read the 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 -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.
- Conditions
- Knee Osteoarthritis
- Being tested
- AMT-Regenera activa, Hyalubrix
- Keywords
- knee osteoartrithis, knee chondropathy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
- Once the samples are obtained, they must be put on the metallic grid of the Rigeneracon
- 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.
- The samples are processed for 6 minutes
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Device: Hyalubrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months overall
Secondary outcomes (1)
IKDC improvement
IKDC patient reported SCORE
Measured: 6 months overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 May 2024
- Study completion15 May 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Brain Wave S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s., Ibismed S.r.l.
- Responsible party
- Sponsor
- Investigators
- Vincenzo Salini, Prof. MD, Principal investigator, Ospedale San RaffaeleCarlo Fiorentini, Prof. MD, Principal investigator, Policlinico San Donato Milanese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123689
- Sponsor's protocol ID
- RE78.22.01
- Status last verified
- Jun 2025
- First submitted
- 27 Oct 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT06123689
- Acronym / sponsor ID
- RE78.22.01
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoartrithis, knee chondropathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Human Brain Wave S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s., Ibismed S.r.l.
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 -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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMT-Regenera activa | Experimental | Device: AMT-Regenera activaAll the patients of the group will be treated with one unique articular injection of autologous micrografts obtained through the Rigenera® Technology |
| Hyalubrix | Active comparator | Device: HyalubrixAll the patients of the group will be treated with one unique articular injection of Sodium Hyaluronate (Hyalubrix 60 -1,5%-2ml vial) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT-Regenera activaPatient'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 | AMT-Regenera activa |
| HyalubrixPatients 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 | Device | Hyalubrix |
Primary outcome
AMT Regenera improvement of pain management
Time frame: 6 months overall
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
1 secondary outcome
IKDC improvement
Time frame: 6 months overall
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Salini, Prof. MD principal investigator
Ospedale San Raffaele
Carlo Fiorentini, Prof. MD principal investigator
Policlinico San Donato Milanese
Questions about this trial
What is this clinical trial studying?
A study testing AMT-Regenera activa and Hyalubrix in people with Knee Osteoarthritis, run by Human Brain Wave S.r.l..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMT Regenera improvement of pain management (time frame: 6 months overall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.