ACTRN12622000530729尚未招募2 期
Autologous Stem Cell Transplant in other Neuro-Inflammatory diseases
St Vincent's Hospital, Sydney0 个研究点目标入组 20 人开始时间: 2022年4月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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 70 Years（—）
- 性别
- All
入选标准
- •HSCT patients with NID
- •- Age 18-65
- •- Age 65-70 (may be considered only if HCT-CI<3 and deemed fit both physically and cognitively by at least two investigators)
- •- Adequate organ function as measured by:
- •oCardiac LV Ejection Fraction > 45%
- •oTotal Lung Capacity > 60%
- •oDLCO/VA > 50%.
- •oNegative serology for active HBV, active HCV and HIV.
- •oNegative CT skeletal survey in patients with CIDP and a para-protein
- •oSerological assessments of haematology, liver, kidney and thyroid function reviewed by transplant physician and specialty input sought were required.
- •- No evidence of chronic infection or significant systemic illness where a treating specialist has concerns about HSCT.
- •- Clearance from treating physician in the case of prior or co-existent malignancy
- •- No current history of substance abuse (drug or alcohol) or other factor (eg: serious psychiatric impairment) that may interfere with patient’s ability to comply with the study procedure and follow up.
- •- Negative pregnancy test.
- •- Sperm collection or ova cryopreservation is to be offered prior to HSCT in those of child-bearing age.
- •- Patients must agree to use a form of effective contraception (either i.e. partner) during and for 3 months after HSCT (females that are either post-menopausal for 12 months prior to randomization or surgically sterile [through hysterectomy or bilateral oophorectomy] are not required to use birth control).
- •- Able to provide informed consent and the absence of mental and cognitive deficits which can interfere with the capability of providing the informed consent.
- •- AHSCT deemed an appropriate high-intensity immunotherapeutic treatment in the opinion of the referring physician.
- •- Published data to support the role of AHSCT for the disease.
- •- Suitability for AHSCT will be determined by a multidisciplinary HSCT panel including a neurologist and haematologists/transplant physicians.
- •- If suitability is contended an expert opinion from and alternate national or international centre involved in AHSCT for AID may be sought.
排除标准
- •- Any patient on the study treatment arm deemed not suitable for transplant by a consensus of HSCT specialists as determined at the HSCT MDT.
- •- Any patient unable to understand the purpose and risks of the study or adhere to the post-transplant management including medication adherence and appointment attendance.
- •- Patients with a predominately progressive form of disease.
- •- Patients where mimics have not been adequately excluded.
- •- Patients unable to undergo MRI scans.
- •- Patients with advanced NID where the risks of transplant are deemed to outweigh potential benefits.
研究者
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