Graft Vs Host DiseaseNCT05167188
Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells
An observational study of Graft Vs Host Disease, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 1 site in Italy.
Trial summary
Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Graft Vs Host Disease
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2021to Mar 2025
- 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 6 months to 99 years
- All sexes
- Child, Adult, Older adult
Study population: Patients (children and adults) developing acute or chronic GvHD after HSCT
Who may be able to join
- Patients (children and adults) developing acute or chronic GvHD after HSCT.
- Age 6 months- month-99 years,
- Landsky-Karnofsky> 70%,
- Acute or chronic GvHD needing further immunosuppressive treatment.
Who cannot join
- Anything not included in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10126
Celeste Cagnazzo, PhD, +39011313 ext. 5171, celeste.cagnazzo@unito.it
About this study
Official title: Prospective Multicenter Study for the Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells - GvHD Damage on MSCs
Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise
- Conditions
- Graft Vs Host Disease
- Being tested
- no intervention
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start14 Oct 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167188
- Sponsor's protocol ID
- GvHD damage on MSCs
- Status last verified
- May 2023
- First submitted
- 24 Nov 2021
- Last updated
- 24 May 2023
- 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study for the Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells - GvHD Damage on MSCs
- ClinicalTrials.gov ID
- NCT05167188
- Acronym / sponsor ID
- GvHD damage on MSCs
- Conditions
- Graft Vs Host Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Dec 2021 (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.
Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (children and adults) developing acute or chronic GvHD after HSCT
Key inclusion criteria (4 listed)
- Patients (children and adults) developing acute or chronic GvHD after HSCT.
- Age 6 months- month-99 years,
- Landsky-Karnofsky> 70%,
- Acute or chronic GvHD needing further immunosuppressive treatment.
Key exclusion criteria (1 listed)
- Anything not included in the inclusion criteria.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
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 Graft Vs Host Disease, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna 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 4 inclusion and 1 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 24 May 2023. 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?
Contact Franca Fagioli, MD (+39011313 ext. 5997, franca.fagioli@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT (time frame: Through study completion, an average of 1 year). 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 24 May 2023.