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Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands (MS-ACT)

A

Amsterdam UMC, location VUmc

Status

Enrolling

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study type

Observational

Funder types

Other

Identifiers

NCT06567197
NL83783.018.23

Details and patient eligibility

About

The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:

  1. Disease activity
  2. Safety and tolerability of aHSCT
  3. Changes in the immune system

Participants will be subjected to frequent visits for five years after treatment with aHSCT. During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS

Exclusion criteria

  • Contra-indications for treatment with aHSCT such as known hypersensitivity to the medication used for aHSCT
  • Clinically relevant comorbidities preventing safe use of medication used for aHSCT
  • Severe clinical depression
  • Active addiction to drugs or alcohol
  • Active infections such as but not limited to tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, HIV or syphilis.
  • Active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix

Trial contacts and locations

2

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Central trial contact

Rick Heijnen, MSc

Data sourced from clinicaltrials.gov

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