Multiple Sclerosis treatment with Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A long-term prospective observational study in the Netherlands

Multiple Sclerosis treatment with Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A long-term prospective observational study in the Netherlands - MS-ACT

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53285

Enrollment

Registered

2023-08-25

Start date

2023-09-06

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All patients who undergo aHSCT for the treatment of RRMS in the Netherlands are eligible to participate in this observational study.

Exclusion criteria

Exclusion criteria: The only exclusion criteria for this observational study is unwillingness to participate or to sign informed consent.

Design outcomes

Primary

Measure	Time frame
Patients will be subjected to frequent visits with clinical, radiological and biomarker follow-up until five years after aHSCT (primary phase and extension phase). During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed. The main study parameters are: 1. no evidence of disease activity (meaning no MS relapses, no disability progression and no MS MRI activity, i.e. NEDA3)	—

Measure

Time frame

Patients will be subjected to frequent visits with clinical, radiological and biomarker follow-up until five years after aHSCT (primary phase and extension phase). During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed. The main study parameters are: 1. no evidence of disease activity (meaning no MS relapses, no disability progression and no MS MRI activity, i.e. NEDA3)

—

Secondary

Measure	Time frame
Secundary study parameters are safety and tolerability of aHSCT, biomarkers and longitudinal analysis of immune reconstitution.	—

Countries

Netherlands

Outcome results