A Phase II study:Haematopoietic Stem Cell Transplantation for highly activetreatment resistant multiple sclerosis .

Phase 2

Recruiting

• Conditions: Relapsing Remitting Multiple Sclerosis; Neurological - Multiple sclerosis; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12616000151437
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Adequate organ function as measured by: Cardiac LV Ejection Fraction greater than 45%, total Lung Capacity greater than 60%, Pulmonary artery pressure less than 50mmHg, DLCO greater than or equal to 50%.
Negative serology for HBV, HCV and HIV.
Negative pregnancy test.
Able to provide informed consent and the absence of mental and cognitive deficits which can interfere with the capability of providing the informed consent.
Absence of severe chronic infection.

Specific Inclusion Criteria for multiple sclerosis
Age between 18-55
EDSS between 2.5-5.5
10 years or less since first treated for MS
And meets criteria (below) on both clinical and MRI grounds, for highly active MS within the past 2 years despite ongoing use of a PBS approved therapy
Clinical
i) a minimum of at least 1 severe relapse with an increase in EDSS of 1 (or 0.5 for those with pre relapse EDSS of 5.5 or above)
in motor, cerebellar or brain stem deficit (or documented changes in neurological examination consistent with these magnitudes)
and/or
ii)incomplete recovery from clinically significant relapses

MRI
i.at least one gadolinium-positive (Gd+) lesion of diameter 3 mm or greater on MRI within the past 6 months.
or
ii.accumulation of at least 0.3 T2 lesions/month on two consecutive MRIs 6–12 months apart.

Previous Treatment with Nataluzimab is allowed but a minimum of 6 months MUST have elapsed since completion of treatment.

Exclusion Criteria

Progressive forms of multiple sclerosis with no evidence of recent disease activity on MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified