Musculoskeletal DiseasesTENET(L4165)NCT05471752
Isolation, Characterization and Evaluation of the Potential of TissuE-resideNt cElls From Waste Musculoskeletal and Associated Connective Tissues
An observational study of Musculoskeletal Diseases, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The general purpose of this study is characterization of tissue-resident cells derived from different musculoskeletal and/or associated connective tissues (such as cartilage, synovial membrane, synovial fluid, bone, adipose tissue and tendons), in order to identify new strategies for the treatment of degenerative and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases
- How many people
- 742 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2022to 11 May 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: males and females pateints, being ≥18 years old, undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair
Who may be able to join
- males and females
- 18 years old
- patients undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair
Who cannot join
- age < 18 years old
- patients unable to sign the Informed Consent
- positivity to virological test (HIV, HCV, HBV, TPHA)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Direzione Scientifica, direzionescientifica.iog@grupposandonato.it
About this study
The general purpose of this study is characterization of tissue-resident cells derived from different musculoskeletal and/or associated connective tissues (such as cartilage, synovial membrane, synovial fluid, bone, adipose tissue and tendons), in order to identify new strategies for the treatment of degenerative and inflammatory musculoskeletal disorders. Cells isolated from different tissue sources will be compared with each other by phenotypic and functional characterization, following culture and treatment with inflammatory elements, drugs and orthobiologics. Moreover, with the aim to assess predictive markers of therapeutic success, a correlation study of the content and properties of the cells isolated from different types of tissue with the clinical profile of the enrolled patients will be conducted.
- Conditions
- Musculoskeletal Diseases
- Medical subject headings
- Musculoskeletal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation beetween patients' age and cell yield
The primary outcome of the study will be to identify possible correlations between the cellular yields and patients age. The data from different tissue sources will be analyzed to assess whether the changes are tissue-specific.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start11 May 2022
- Primary completion11 May 2027 (estimated)
- Study completion11 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 742 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471752
- Sponsor's protocol ID
- TENET(L4165)
- Acronym
- TENET(L4165)
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation, Characterization and Evaluation of the Potential of TissuE-resideNt cElls From Waste Musculoskeletal and Associated Connective Tissues
- ClinicalTrials.gov ID
- NCT05471752
- Acronym / sponsor ID
- TENET(L4165) / TENET(L4165)
- Conditions
- Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 742 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 11 May 2027 (estimated)
- First posted
- 25 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.
The general purpose of this study is characterization of tissue-resident cells derived from different musculoskeletal and/or associated connective tissues (such as cartilage, synovial membrane, synovial fluid, bone, adipose tissue and tendons), in order to identify new strategies for the treatment of degenerative and inflammatory musculoskeletal disorders. Cells isolated from different tissue sources will be compared with each other by phenotypic and functional characterization, following culture and treatment with inflammatory elements, drugs and orthobiologics. Moreover, with the aim to assess predictive markers of therapeutic success, a correlation study of the content and properties of the cells isolated from different types of tissue with the clinical profile of the enrolled patients will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- males and females pateints, being ≥18 years old, undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair
Key inclusion criteria (3 listed)
- males and females
- patients undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair
Key exclusion criteria (3 listed)
- age < 18 years old
- patients unable to sign the Informed Consent
- positivity to virological test (HIV, HCV, HBV, TPHA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation beetween patients' age and cell yield
Time frame: 5 years
The primary outcome of the study will be to identify possible correlations between the cellular yields and patients age. The data from different tissue sources will be analyzed to assess whether the changes are tissue-specific.
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 25 Jul 2022.
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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.
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 Musculoskeletal Diseases, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Jul 2022. 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?
Contact Direzione Scientifica (00390266214048, direzionescientifica.iog@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation beetween patients' age and cell yield (time frame: 5 years). 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 25 Jul 2022.