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

Austin Health0 个研究点目标入组 20 人开始时间: 2016年2月9日最近更新: 2020年1月13日

试验速览

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•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
•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)
•ii)incomplete recovery from clinically significant relapses
•i.at least one gadolinium-positive (Gd+) lesion of diameter 3 mm or greater on MRI within the past 6 months.
•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.

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

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