NCT07635693Recruiting
ATLG Levels in Autologous HSCT for Multiple Sclerosis
ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 4 May 2026
- Primary completion date
- 4 May 2028
- Lead sponsor
- Ciceri Fabio
- Diseases
- Multiple sclerosis
- NCT number
- NCT07635693
What you commit to
- Study type: Observational
- Planned participants: 20
- From 4 May 2026 to the primary completion date, 4 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections)
Other
- Subjects that did not accept to sign the informed consent.
- Use of ATG.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.