Osteoarthritis, KneeIMPRESANCT06384040
Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment
An observational study of Osteoarthritis, Knee, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- platelet-rich plasma knee injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 30 Oct 2024
- Phase
- Observational
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Knee OA patients will be enrolled at the outpatient clinic of UO1 and UO2 during the routine activity. They will receive a thorough description of the project and, if willing to participate, they will sign the informed consent. The patient number needed in the study has been calculated to ensure a proper representation of the described phenotypes (Soul J et al, 2018). The patients will undergo imaging and clinical evaluations; the respective results will be analysed and correlated with laboratory evaluations. Moreover, all patients will undergo biologic sample harvesting (as detailed below) and afterwards PRP injection. We will collect peripheral blood (PB) samples and, when available, synovial fluid (SF) from the patients prior to PRP injection
Who may be able to join
- men/women, aged >40 - <75 years), OA grade 2-3, BMI <40, baseline WOMAC PAIN >1.75 -<4, >1 conservative therapy failed. Diagnosis of knee OA according to the American College of Rheumatology (ACR) classification criteria (Altman, 1986) .
- Ability to give informed consent.
Who cannot join
- Presence of active infection or abnormal knee effusion on Day 1 at pre-injection of PRP
- Diagnosis of chronic inflammatory disease (i.e. rheumatoid arthritis, reactive arthritis, psoriatic arthritis, chondromalacia, arthritis secondary to other inflammatory diseases)
- Untreated acute traumatic injury, presence of a symptomatic meniscal tear, valgus/varus deformity judged by the investigator to be clinically significant, in the index knee
- Recent (within 3-6 months) arthroscopy, open surgery, intra-articular steroid injections, intra-articular hyaluronic acid (HA) injections, systemic steroid treatment, malignancy
- Any serious, non-malignant, significant, acute, or chronic medical condition or active psychiatric illness that, in the investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
- Recent (within 30 days) use of any investigational drug or device prior to screening
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Berardo Di Matteo, 02 82241, reumatologia@humanitas.it
About this study
Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation.
- Conditions
- Osteoarthritis, Knee
- Being tested
- platelet-rich plasma knee injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich plasma knee injectionProcedure or surgery
platelet-rich plasma knee injection and observation for 12 months for definition of responder and non responder
| Study group | Role | What they receive |
|---|---|---|
| PRP responder | response to treatment will be established in the presence of >40% improvement of pain and/or motility Receives: Procedure: platelet-rich plasma knee injection | |
| PRP non responder | response to treatment will be established in the presence of <40% improvement of pain and/or motility Receives: Procedure: platelet-rich plasma knee injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression
We will collect peripheral blood (PB) samples and cellular and molecular components in these samples will be characterized by measuring gene expression and protein levels of soluble factors involved in inflammatory pathways, with specific attention to Wnt and IL1 signaling pathways, and PTX3, and by performing a complete immunophenotype. We will use computational clustering approaches applied to single cell FACS data (Phenograph, FlowSOM, or similar) to identify phenotypic subsets in an unbiased way.
Measured: 18 months
Secondary outcomes (1)
To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment
We will define the overall oxidative status in the patients at baseline, by measuring a set of parameters related to enzymatic and non-enzymatic antioxidant systems, comprising the total antioxidant capacity, total glutathione, catalase activity, advanced glycation end products, HNE adducts, vitamin E and C, in the serum and SF, when available.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Nov 2021
- Primary completion4 Sep 2023
- Study completion30 Oct 2024 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Ortopedico Rizzoli
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384040
- Sponsor's protocol ID
- GR-2019-12370692
- Acronym
- IMPRESA
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment
- ClinicalTrials.gov ID
- NCT06384040
- Acronym / sponsor ID
- IMPRESA / GR-2019-12370692
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Istituto Ortopedico Rizzoli
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 25 Apr 2024 (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 highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP responder | – | Procedure: platelet-rich plasma knee injectionresponse to treatment will be established in the presence of >40% improvement of pain and/or motility |
| PRP non responder | – | Procedure: platelet-rich plasma knee injectionresponse to treatment will be established in the presence of <40% improvement of pain and/or motility |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Knee OA patients will be enrolled at the outpatient clinic of UO1 and UO2 during the routine activity. They will receive a thorough description of the project and, if willing to participate, they will sign the informed consent. The patient number needed in the study has been calculated to ensure a proper representation of the described phenotypes (Soul J et al, 2018). The patients will undergo imaging and clinical evaluations; the respective results will be analysed and correlated with laboratory evaluations. Moreover, all patients will undergo biologic sample harvesting (as detailed below) and afterwards PRP injection. We will collect peripheral blood (PB) samples and, when available, synovial fluid (SF) from the patients prior to PRP injection
Key inclusion criteria (2 listed)
- men/women, aged >40 - <75 years), OA grade 2-3, BMI <40, baseline WOMAC PAIN >1.75 -<4, >1 conservative therapy failed. Diagnosis of knee OA according to the American College of Rheumatology (ACR) classification criteria (Altman, 1986) .
- Ability to give informed consent.
Key exclusion criteria (6 listed)
- Presence of active infection or abnormal knee effusion on Day 1 at pre-injection of PRP
- Diagnosis of chronic inflammatory disease (i.e. rheumatoid arthritis, reactive arthritis, psoriatic arthritis, chondromalacia, arthritis secondary to other inflammatory diseases)
- Untreated acute traumatic injury, presence of a symptomatic meniscal tear, valgus/varus deformity judged by the investigator to be clinically significant, in the index knee
- Recent (within 3-6 months) arthroscopy, open surgery, intra-articular steroid injections, intra-articular hyaluronic acid (HA) injections, systemic steroid treatment, malignancy
- Any serious, non-malignant, significant, acute, or chronic medical condition or active psychiatric illness that, in the investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
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 |
|---|---|---|
| platelet-rich plasma knee injectionplatelet-rich plasma knee injection and observation for 12 months for definition of responder and non responder | Procedure or surgery | PRP non responder, PRP responder |
Primary outcome
knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression
Time frame: 18 months
We will collect peripheral blood (PB) samples and cellular and molecular components in these samples will be characterized by measuring gene expression and protein levels of soluble factors involved in inflammatory pathways, with specific attention to Wnt and IL1 signaling pathways, and PTX3, and by performing a complete immunophenotype. We will use computational clustering approaches applied to single cell FACS data (Phenograph, FlowSOM, or similar) to identify phenotypic subsets in an unbiased way.
1 secondary outcome
To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression (time frame: 18 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 30 Apr 2024.