ACTRN12616000151437
Recruiting
Phase 2
A Phase II study:Haematopoietic Stem Cell Transplantation for highly activetreatment resistant multiple sclerosis .
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Austin Health
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Progressive forms of multiple sclerosis with no evidence of recent disease activity on MRI.
Outcomes
Primary Outcomes
Not specified
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