Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.

Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023560-40-SE

Enrollment

120

Registered

2010-12-21

Start date

2011-03-23

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Relapsing-remitting multiple sclerosis MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Tysabri Pharmaceutical Form: INN or Proposed INN: NATALIZUMAB CAS Number: 189261-10-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 18 -55, inclusive. 2. Diagnosis of MS using McDonald criteria of clinically definite MS. 3. An EDSS of 2.0 to 6.0. 4. Inflammatory disease despite treatment with standard disease modifying therapy including at least 6 months of interferon or copaxone. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy. 2. More than six cycles prior therapy with mitoxantrone. 3. Prior history of malignancy except localized basal cell, squameous skin cancer or carcinoma in situ of the cervix. Other malignancies for whoich the patient is judged to be cured, such as haed and neck cancer, or breast cancer wil lbe considered on an individual basis. 4. Positive pregnancy test. 5. Inability or unwillingness to pursue effective means of birth control....

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of autologous HSCT versus the FDA approved standard of care, natalizumab, for inflammatory MS failing alternate approved therapy. (The original protocol from Northwestern University, Chicago, includes interferon, glatiramer acetate and mitoxantrone as comparators as well; we will only use natalizumab.) ;Secondary Objective: ;Primary end point(s): Disease progression, defined as a 1-point increase in the EDSS on consecutive evaluations at least 6 months apart and not due to a non-MS disease process. Patients will be followed for 5 years after randomization.	—

Measure

Time frame

Main Objective: To assess the efficacy of autologous HSCT versus the FDA approved standard of care, natalizumab, for inflammatory MS failing alternate approved therapy. (The original protocol from Northwestern University, Chicago, includes interferon, glatiramer acetate and mitoxantrone as comparators as well; we will only use natalizumab.) ;Secondary Objective: ;Primary end point(s): Disease progression, defined as a 1-point increase in the EDSS on consecutive evaluations at least 6 months apart and not due to a non-MS disease process. Patients will be followed for 5 years after randomization.

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Secondary

Measure	Time frame
Secondary end point(s): Number of relapses Ambulation index 25 foot timed walk 9 hole PEG test PASAT-3 second and PASAT-2 second MRI enhancing lesions and T1 and T2 burden of disease per CombiRx MRI protocol SF-36 and MSQOL Scripps NRS Survival	—

Countries

Brazil, Canada, Sweden, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026