Osteoarthritis, KneePATTERNNCT05447767
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg (PATTERN)
A study testing KIT BMAC and at-SVF FIDIA in people with Osteoarthritis, Knee, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Osteoarthritis (OA) is a degenerative joint disease characterised by chronic pain, degradation and loss of articular cartilage, osteophyte formation and varying degrees of synovial inflammation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- KIT BMAC and at-SVF FIDIA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2021to 29 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75;
- Patients affected by knee OA KL 2-3;
- Patients understanding the nature of the study and providing their informed consent to participation;
- Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
- Body mass index (BMI) ≤ 40 kg/m2;
- Ability to provide written informed consent and can understand and comply with the requirements of the study.
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- Patients aged 18-75;
- Patients affected by knee OA KL 2-3;
- Patients understanding the nature of the study and providing their informed consent to participation;
- Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
- Body mass index (BMI) ≤ 40 kg/m2;
- Ability to provide written informed consent and can understand and comply with the requirements of the study.
Who cannot join
- A 4-arms randomized clinical trial in 240 patients affected by knee OA KL 2-3. Treatment groups: 1) intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of adipose tissue enriched in SVF (at-SVF) , 4) intraosseous and intra-articular injection of at-SVF.
- Patients with known inflammatory diseases at the time of enrolment.
- Patients who are not allowed to undergo the study procedures involving imaging (X-rays, MRI) based on Investigator's judgement.
- A history of local anaesthetic and anticoagulant drug allergy;
- Clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee;
- Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening;
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- Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening;
- Patients who received intra-articular injection of corticosteroids, PRP or HA within the previous 3 months;
- Use of systemic immunosuppressants within 6 weeks prior to screening;
- Patients with a history of invasive malignancies (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years;
- Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for three months later.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg. (CO-2019-12370720 Prof. Kon BANDO DI RICERCA FINALIZZATA 2019)
Osteoarthritis (OA) is a degenerative joint disease characterised by chronic pain, degradation and loss of articular cartilage, osteophyte formation and varying degrees of synovial inflammation.
Today, most of the available conservative treatments provide temporary relief of symptoms but have no effect on the cause and progression of the disease. Mesenchymal stem cells (MSC) have emerged as a durable and effective conservative treatment option for OA.
Read more
They are tissue cell-rich concentrates that have demonstrated immunomodulatory activities in several in vitro and in vivo studies, particularly in orthopaedics.
Thus, "minimal handling" methods for the intraoperative production of tissue cell-rich concentrates has become a widespread strategy in clinical practice. In particular, bone marrow aspirate concentrate (BMAC) and adipose tissue enriched SVF (at-SVF), i.e. the so-called 'orthobiologics', have proven to be cost-effective and promising sources with a high safety profile and positive short-term clinical results.
Despite growing evidence on the use of orthobiologics, the different methods of preparation and administration and the lack of meaningful data collection do not allow for a clear understanding of the true efficacy of these treatments, resulting in a lack of patient-specific indications.
Although the most common method of administering regenerative Although the most common method of administering regenerative medicinal products is by intra-articular injection, more recently it has been shown that in patients with OA the subchondral bone also undergoes significant pathological changes. Given this evidence, intra-osseous (bone-cartilage interface) injections of biological products may represent a promising approach.
Read the detailed description
Multicentre, open-label, randomised, four-arm clinical trial. Patients enrolled in this clinical trial will undergo scheduled surgery for the treatment of grade 2-3 OA KL. After enrolment, patients will be assigned to 4 treatment groups:
- intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of at-SVF, 4) intra-osseous and intra-articular injection of at-SVF. Medical history, clinical and radiological features, and serum samples will be collected for each patient at baseline, along with cell counts of each product injected.
The primary efficacy objective is the mean change from baseline to 12 months in the mean scores of the Pain and Symptoms in the Knee and Osteoarthritis Outcome Score (KOOS) subscales for each arm.
The KOOS subscale scores of pain and symptoms will be aggregated and averaged as the primary outcome.
Secondary objectives
- Patient profiling through the collection of clinical, radiological and anamnestic data, and through high-throughput proteomic analysis of serum samples and validation of differentially expressed markers to identify possible specific characteristics of responder and non-responder patients to each treatment.
- Whole organ magnetic resonance imaging (WORMS) at 6, 12 months from baseline;
- Presence/appearance of structural pathological features detected by MRI at 6, 12 months compared to baseline;.
This is a post-market clinical investigation of the bone marrow aspirate concentrate (BMAC) and adipose tissue enriched in SVF (at-SVF) for the treatment of OA.
The study is a multicentric, open-label, prospective, 4-arms, in male and female Patients, aged between 18 and 75 years , affected by knee OA Kellgren-Lawrence (KL) 2-3.
The primary objective of this study is to develop an algorithm for the determination of the best treatment for each OA patient, the secondary objective is to identify responder patients to each treatment and to correlate their biologic profile, based on protein expression patterns in the blood samples pre and post-treatment, and the third objective is to compare two autologous bone marrow-derived and adipose-derived treatments on different OA phenotype patients. High-throughput proteomic analysis will be performed on the patients' sera from the 10 top and 10 worst clinical performers in each group at 6 months. Differentially expressed biomarkers will be validated on the whole cohort of patients by commercially available serum tests (ELISA). Data derived from the clinical trial and biomarker assessment will identify all possible covariates influencing the clinical outcome. A principal components analysis will be the base for the development of a prediction algorithm for identification of responders and non-responders to each treatment, in order to provide indications for a personalized approach for knee OA treatment. The markers identified during the high-throughput analysis will be validated using standard diagnostic procedures. A specific diagnostic kit made of reagents and methods for the assessment of the selected and validated biomarkers will be produced and patented. The proteomics analysis on serum samples will be performed at IRCCS Istituto Ortopedico Galeazzi, while markers validation assays will be performed at IRCCS Humanitas.
240 patients affected by knee OA KL 2-3 will enrolled and randomized in 4 treatment groups:
- intra-articular injection of BMAC;
- intra-osseous and intra-articular injection of BMAC;
- intra-articular injection of at- SVF;
- intraosseous and intra-articular injection of at-SVF. Medical history, clinical and radiological features as well as a serum samples, will be collected for each patient at baseline. Complete cell count will be performed on all injected samples.
Patients will be evaluated at the investigational site for 12 months: at Visit 1 (screening visit, day -90 before treatment), Visit 2 (day of treatment), Visit 3 (Follow-up +3 Months after treatment), Visit 4 (Follow-up +6 Months after treatment), Visit 5 (Follow-up +12 Months after treatment).
Adverse events should be assessed and documented at each scheduled visit starting from signature of informed consent. Adverse events will be evaluated at every visit, with an evaluation of pain and the measurement of health status (quality of life and functional scores); radiological assessments (MRI) will be performed at visit 1, visit 4 and visit 5.
The enrolment will go on until 60 patients are allocated to each group (allocation:1:1:1:1).
Baseline visit/Procedure Visit (V2, Day 0)
During this visit, the investigator will:
- Review of inclusion/exclusion criteria and confirm patient's eligibility
- Administer a urine pregnancy test to females of childbearing potential
- Peripheral blood samples
- Harvesting Adipose/Bone Tissue preparation with at-SVF/BMAC Kit
- Injection can be executed under arthroscopical control
- Record patient's concomitant treatments and medications
- Record any AEs
- Cell count of injected products
Follow-up Visit (V3, 3 months ± 4 weeks)
During this visit, the investigator will:
- Perform physical examination
- Perform the knee assessment and complete:
- Administer to the patient the following questionnaires:
- KOOS subscales
- IKDC questionnaire
- VAS score
- Record patient's concomitant treatments and medications
- Record any AEs
Follow-up Visit (V4, 6 months ± 6 weeks)
During this visit, the investigator will:
- Perform physical examination
- Perform the knee assessment and complete:
- Administer to the patient the following questionnaires:
- KOOS subscales
- IKDC questionnaire
- Vas Score
- Administer a urine pregnancy test to females of childbearing potential, before the MR Imaging
- Submit patient to a MRI
- Record patient's concomitant treatments and medications
- Record any AEs
Follow-up Visit (V4, 12 months ± 8 weeks)
During this visit, the investigator will:
- Perform physical examination
- Perform the knee assessment and complete:
- Administer to the patient the following questionnaires:
- KOOS subscales
- IKDC questionnaire
- Vas Score
- Administer a urine pregnancy test to females of childbearing potential, before the MR Imaging
- Submit patient to a MRI
- Record patient's concomitant treatments and medications
- Record any AEs
In case of premature withdrawal from the study for whatever reason, the same assessments described for Visit 4 will be performed and recorded in an "Early termination visit".
The Investigator will duly record the reason for premature withdrawal in the source documents and then in the appropriate section of the CRF. Visit 4 (12 months ± 8 weeks) or the 'Early termination Visit' will represent the conclusion of patient's participation in the study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- KIT BMAC, at-SVF FIDIA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIT BMACDevice
intra-articular infiltration of BMAC
KIT BMACDevice
intra-articular and intra-osseous infiltration of BMAC
at-SVF FIDIADevice
intra-articular infiltration of at-SVF
at-SVF FIDIADevice
intra-articular and intra-osseous infiltration of at-SVF
| Study group | Role | What they receive |
|---|---|---|
| intra-articular injection of BMAC | Active comparator | intra-articular injection of BMAC Receives: Device: KIT BMAC |
| intra-osseous and intra-articular injection of BMAC | Active comparator | intra-osseous and intra-articular injection of BMAC Receives: Device: KIT BMAC |
| intra-articular injection of at- SVF | Active comparator | intra-articular injection of at- SVF Receives: Device: at-SVF FIDIA |
| intraosseous and intra-articular injection of at-SVF | Active comparator | intraosseous and intra-articular injection of at-SVF Receives: Device: at-SVF FIDIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean KOOS score change from baseline to 12 months.
KOOS, IKDC and VAS questionnaires will be administered during screening visit and follow-up visits in order to monitor the evolution of the patients. KOOS subscales scores of Pain and Symptoms will be aggregated and averaged as primary outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start27 Sep 2021
- Primary completion27 Mar 2023
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy, Fidia Farmaceutici s.p.a.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447767
- Sponsor's protocol ID
- 2921
- Acronym
- PATTERN
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg. (CO-2019-12370720 Prof. Kon BANDO DI RICERCA FINALIZZATA 2019)
- ClinicalTrials.gov ID
- NCT05447767
- Acronym / sponsor ID
- PATTERN / 2921
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy, Fidia Farmaceutici s.p.a.
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 7 Jul 2022 (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.
Osteoarthritis (OA) is a degenerative joint disease characterised by chronic pain, degradation and loss of articular cartilage, osteophyte formation and varying degrees of synovial inflammation.
Today, most of the available conservative treatments provide temporary relief of symptoms but have no effect on the cause and progression of the disease. Mesenchymal stem cells (MSC) have emerged as a durable and effective conservative treatment option for OA.
They are tissue cell-rich concentrates that have demonstrated immunomodulatory activities in several in vitro and in vivo studies, particularly in orthopaedics.
Thus, "minimal handling" methods for the intraoperative production of tissue cell-rich concentrates has become a widespread strategy in clinical practice. In particular, bone marrow aspirate concentrate (BMAC) and adipose tissue enriched SVF (at-SVF), i.e. the so-called 'orthobiologics', have proven to be cost-effective and promising sources with a high safety profile and positive short-term clinical results.
Despite growing evidence on the use of orthobiologics, the different methods of preparation and administration and the lack of meaningful data collection do not allow for a clear understanding of the true efficacy of these treatments, resulting in a lack of patient-specific indications.
Although the most common method of administering regenerative Although the most common method of administering regenerative medicinal products is by intra-articular injection, more recently it has been shown that in patients with OA the subchondral bone also undergoes significant pathological changes. Given this evidence, intra-osseous (bone-cartilage interface) injections of biological products may represent a promising approach.
Detailed description
Multicentre, open-label, randomised, four-arm clinical trial. Patients enrolled in this clinical trial will undergo scheduled surgery for the treatment of grade 2-3 OA KL. After enrolment, patients will be assigned to 4 treatment groups:
- intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of at-SVF, 4) intra-osseous and intra-articular injection of at-SVF. Medical history, clinical and radiological features, and serum samples will be collected for each patient at baseline, along with cell counts of each product injected.
The primary efficacy objective is the mean change from baseline to 12 months in the mean scores of the Pain and Symptoms in the Knee and Osteoarthritis Outcome Score (KOOS) subscales for each arm.
The KOOS subscale scores of pain and symptoms will be aggregated and averaged as the primary outcome.
Secondary objectives
- Patient profiling through the collection of clinical, radiological and anamnestic data, and through high-throughput proteomic analysis of serum samples and validation of differentially expressed markers to identify possible specific characteristics of responder and non-responder patients to each treatment.
- Whole organ magnetic resonance imaging (WORMS) at 6, 12 months from baseline;
- Presence/appearance of structural pathological features detected by MRI at 6, 12 months compared to baseline;.
This is a post-market clinical investigation of the bone marrow aspirate concentrate (BMAC) and adipose tissue enriched in SVF (at-SVF) for the treatment of OA.
The study is a multicentric, open-label, prospective, 4-arms, in male and female Patients, aged between 18 and 75 years , affected by knee OA Kellgren-Lawrence (KL) 2-3.
The primary objective of this study is to develop an algorithm for the determination of the best treatment for each OA patient, the secondary objective is to identify responder patients to each treatment and to correlate their biologic profile, based on protein expression patterns in the blood samples pre and post-treatment, and the third objective is to compare two autologous bone marrow-derived and adipose-derived treatments on different OA phenotype patients. High-throughput proteomic analysis will be performed on the patients' sera from the 10 top and 10 worst clinical performers in each group at 6 months. Differentially expressed biomarkers will be validated on the whole cohort of patients by commercially available serum tests (ELISA). Data derived from the clinical trial and biomarker assessment will identify all possible covariates influencing the clinical outcome. A principal components analysis will be the base for the development of a prediction algorithm for identification of responders and non-responders to each treatment, in order to provide indications for a personalized approach for knee OA treatment. The markers identified during the high-throughput analysis will be validated using standard diagnostic procedures. A specific diagnostic kit made of reagents and methods for the assessment of the selected and validated biomarkers will be produced and patented. The proteomics analysis on serum samples will be performed at IRCCS Istituto Ortopedico Galeazzi, while markers validation assays will be performed at IRCCS Humanitas.
240 patients affected by knee OA KL 2-3 will enrolled and randomized in 4 treatment groups:
- intra-articular injection of BMAC;
- intra-osseous and intra-articular injection of BMAC;
- intra-articular injection of at- SVF;
- intraosseous and intra-articular injection of at-SVF. Medical history, clinical and radiological features as well as a serum samples, will be collected for each patient at baseline. Complete cell count will be performed on all injected samples.
Patients will be evaluated at the investigational site for 12 months: at Visit 1 (screening visit, day -90 before treatment), Visit 2 (day of treatment), Visit 3 (Follow-up +3 Months after treatment), Visit 4 (Follow-up +6 Months after treatment), Visit 5 (Follow-up +12 Months after treatment).
Adverse events should be assessed and documented at each scheduled visit starting from signature of informed consent. Adverse events will be evaluated at every visit, with an evaluation of pain and the measurement of health status (quality of life and functional scores); radiological assessments (MRI) will be performed at visit 1, visit 4 and visit 5.
The enrolment will go on until 60 patients are allocated to each group (allocation:1:1:1:1).
Baseline visit/Procedure Visit (V2, Day 0)
During this visit, the investigator will:
- Review of inclusion/exclusion criteria and confirm patient's eligibility
- Administer a urine pregnancy test to females of childbearing potential
- Peripheral blood samples
- Harvesting Adipose/Bone Tissue preparation with at-SVF/BMAC Kit
- Injection can be executed under arthroscopical control
- Record patient's concomitant treatments and medications
- Record any AEs
- Cell count of injected products
Follow-up Visit (V3, 3 months ± 4 weeks)
During this visit, the investigator will:
- Perform physical examination
- Perform the knee assessment and complete:
- Administer to the patient the following questionnaires:
- KOOS subscales
- IKDC questionnaire
- VAS score
- Record patient's concomitant treatments and medications
- Record any AEs
Follow-up Visit (V4, 6 months ± 6 weeks)
During this visit, the investigator will:
- Perform physical examination
- Perform the knee assessment and complete:
- Administer to the patient the following questionnaires:
- KOOS subscales
- IKDC questionnaire
- Vas Score
- Administer a urine pregnancy test to females of childbearing potential, before the MR Imaging
- Submit patient to a MRI
- Record patient's concomitant treatments and medications
- Record any AEs
Follow-up Visit (V4, 12 months ± 8 weeks)
During this visit, the investigator will:
- Perform physical examination
- Perform the knee assessment and complete:
- Administer to the patient the following questionnaires:
- KOOS subscales
- IKDC questionnaire
- Vas Score
- Administer a urine pregnancy test to females of childbearing potential, before the MR Imaging
- Submit patient to a MRI
- Record patient's concomitant treatments and medications
- Record any AEs
In case of premature withdrawal from the study for whatever reason, the same assessments described for Visit 4 will be performed and recorded in an "Early termination visit".
The Investigator will duly record the reason for premature withdrawal in the source documents and then in the appropriate section of the CRF. Visit 4 (12 months ± 8 weeks) or the 'Early termination Visit' will represent the conclusion of patient's participation in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| intra-articular injection of BMAC | Active comparator | Device: KIT BMACintra-articular injection of BMAC |
| intra-osseous and intra-articular injection of BMAC | Active comparator | Device: KIT BMACintra-osseous and intra-articular injection of BMAC |
| intra-articular injection of at- SVF | Active comparator | Device: at-SVF FIDIAintra-articular injection of at- SVF |
| intraosseous and intra-articular injection of at-SVF | Active comparator | Device: at-SVF FIDIAintraosseous and intra-articular injection of at-SVF |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged 18-75;
- Patients affected by knee OA KL 2-3;
- Patients understanding the nature of the study and providing their informed consent to participation;
- Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
- Body mass index (BMI) ≤ 40 kg/m2;
Key exclusion criteria (12 listed)
- A 4-arms randomized clinical trial in 240 patients affected by knee OA KL 2-3. Treatment groups: 1) intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of adipose tissue enriched in SVF (at-SVF) , 4) intraosseous and intra-articular injection of at-SVF.
- Patients with known inflammatory diseases at the time of enrolment.
- Patients who are not allowed to undergo the study procedures involving imaging (X-rays, MRI) based on Investigator's judgement.
- A history of local anaesthetic and anticoagulant drug allergy;
- Clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee;
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 |
|---|---|---|
| KIT BMACintra-articular infiltration of BMAC | Device | intra-articular injection of BMAC |
| KIT BMACintra-articular and intra-osseous infiltration of BMAC | Device | intra-osseous and intra-articular injection of BMAC |
| at-SVF FIDIAintra-articular infiltration of at-SVF | Device | intra-articular injection of at- SVF |
| at-SVF FIDIAintra-articular and intra-osseous infiltration of at-SVF | Device | intraosseous and intra-articular injection of at-SVF |
Primary outcome
The mean KOOS score change from baseline to 12 months.
Time frame: 12 months
KOOS, IKDC and VAS questionnaires will be administered during screening visit and follow-up visits in order to monitor the evolution of the patients. KOOS subscales scores of Pain and Symptoms will be aggregated and averaged as primary outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIT BMAC and at-SVF FIDIA in people with Osteoarthritis, Knee, run by Istituto Clinico Humanitas at 1 site in Italy.
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 12 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
The mean KOOS score change from baseline to 12 months. (time frame: 12 months). 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 2 May 2025.