ACTRN12619000348156招募中2 期
A study to evaluate the safety of Autologous Haematopoietic Stem Cell Transplantation in patients with highly active treatment resistant multiple sclerosis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •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.
- •5.Females of childbearing potential must
- •a. have a negative pregnancy test at baseline prior to entry into the treatment period
- •b. use simultaneously two forms of effective contraception (either i.e partner) during and for 3 months after HSCT
- •c. females that are either post-menopausal for 12 months prior to entry into the treatment period or surgically sterile (through hysterectomy or bilateral oophorectomy) are not required to use birth control.
- •6. Able to provide informed consent and the absence of mental and cognitive deficits which can interfere with the capability of providing the informed consent for participation in the study prior to the Screening.
排除标准
- •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%
- •e)hypertension, not controlled by prescribed medications
- •4.Participants with any of the following pulmonary conditions:
- •a)severe respiratory disease or pulmonary fibrosis;
- •b)tuberculosis, except for history of successfully treated tuberculosis or history of
- •prophylactic treatment after positive PPD skin reaction
- •c)abnormal chest x-ray suggestive of active pulmonary disease;
- •d)abnormal Pulmonary Function Tests: FEV1, FVC values lower than 70% of
- •predicted, DLCO values lower than 60% of predicted.
- •5.Participants with any of the following hepatic conditions
- •a)known history of alcohol abuse, chronic liver or biliary disease
- •b)total bilirubin greater than the upper limit of the normal range, unless in context of
- •Gilbert’s syndrome
- •c)conjugated bilirubin greater than the upper limit of the normal range
- •d)AST, ALT greater than 2 times the upper limit of the normal range
- •e)alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal
- •f) gamma-glytamyl-transferase (GGT) greater than 3 times the upper limit of the normal
- •6. Participants with abnormal laboratory values
- •a)serum creatinine >150 µmol/L.
- •b)white blood cell (WBC) count <3.5x109/L or lymphocyte count <0.8x109/L
- •7.Participants with any of the following neurological or psychiatric conditions
- •a)history of substance abuse (drug or alcohol) or any other factor (i.e., serious
- •psychiatric condition) that may interfere with the subject’s ability to cooperate and
- •comply with the study procedures
- •b)progressive neurological disorder, other than MS, which may affect participation in
- •the study or require the use of medications not allowed by the protocol.
- •8.Participants unable to undergo MRI scans, including history of severe hypersensitivity
- •to gadolinium
- •9.Participation in any clinical research study evaluating another investigational drug or
- •therapy within 6 months prior to baseline.
- •10.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
- •female after conception and
- •11.Participants unwilling to use effective contraception
研究者
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