NCT07635693 ATLG Levels in Autologous HSCT for Multiple Sclerosis
| NCT ID | NCT07635693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ciceri Fabio |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2028-05-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-05-04 with a primary completion date of 2028-05-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, observational, biological, multicenter study to investigate IR profile, ATLG dynamics, main HSCT and disease outcomes in MS. This study will provide a preliminary descriptive evaluation of key study parameters, including ATLG pharmacokinetics and immune reconstitution trends, as well as an initial assessment of variability (e.g., dispersion of immunological biomarkers), to support the interpretation of results and the design of future studies. Since this is an observational study, no clinical decision will be made, and the interim analysis will not have an impact of the study conduction, and it will not be a stopping rule.
Eligibility Criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Adult patients (age \>/= 18y) * Diagnosis of MS * Confirmed program of autologous HSCT according to standard EBMT indications (any conditioning regimen considered standard, BEAM or Cyclophosphamide) * ATLG (total dose 30 mg/kg over 3 days: 10 mg/kg on days -3, -2 and -1) in the conditioning regimen. Exclusion Criteria: * Subjects that did not accept to sign the informed consent. * Use of ATG. * Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07635693 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07635693 currently recruiting?
Yes, NCT07635693 is actively recruiting participants. Contact the research team at greco.raffaella@hsr.it for enrollment information.
Where is the NCT07635693 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07635693 clinical trial?
NCT07635693 is sponsored by Ciceri Fabio. The trial plans to enroll 20 participants.
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