ACTRN12619000348156
Recruiting
Phase 2
A study to evaluate the safety of Autologous Haematopoietic Stem Cell Transplantation in patients with highly active treatment resistant multiple sclerosis.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Alfred Health
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female participants aged 18\-60 with MS (2017 revised McDonald criteria)
- •2\.Expanded Disability Status Scale (EDSS) score between 0 and 6
- •3\.Highly active RRMS despite continuing to use conventional treatment for RRMS within the past 2 years.
- •Definition of ‘highly active’ RRMS
- •1\.Greater than or equal to 1 severe relapses (Change in EDSS greater than or equal to 1 or 0\.5 for those with pre relapse EDSS greater than or equal to 5\.5\) (or documented changes in neurological examination consistent with these magnitudes) and/or incomplete recovery from clinically significant relapses within the last 12 months
- •2\.Greater than or equal to 1 gadolinium\-positive (Gd\+) lesion of diameter greater than or equal to 3 mm on MRI within the past 6 months.
- •3\.Accumulation of any new T2 lesions on follow up MRI scans
- •1\.Change in EDSS greater than or equal to 1 or 0\.5 for those with pre relapse EDSS greater than or equal to 5\.5\)
- •2\.evidence of new MRI activity either T1 or T2 performed on follow up MRI scans
- •4\.Neurologically stable participants with no evidence of relapse for at least 30 days prior to study entry into the treatment period.
Exclusion Criteria
- •1\.Participants with a non\-relapsing form of MS (primary or secondary progressive MS)
- •2\.Participants with any medically unstable condition, as assessed by the primary treating physician.
- •3\.Participants with any of the following cardiovascular conditions:
- •a)history of cardiac arrest;
- •b)myocardial infarction within the past 6 months prior to enrolment or with current
- •unstable ischemic heart disease
- •c)cardiac failure at time of Screening (Class III, according to New York Heart
- •Association Classification) or any severe cardiac disease as determined by the
- •investigator.
- •d)Left Ventricular (LV) ejection fraction \< 45%
Outcomes
Primary Outcomes
Not specified
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