ISRCTN52651778已完成未知
TRIal designs for DElivery of Novel Therapies for Neurodegeneration
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33543141/ protocol (added 08/02/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Confirmed diagnosis of HD through genetic testing (CAG=39)
- •2. =18 years of age
- •3. Stage I or II disease (assessed using the Total Functional Capacity Scale with a score equal to 12 or below) and diagnosed as having motor onset
- •4. Participant is ambulatory
排除标准
- •1. People without capacity to consent to the trial
- •2. Any ongoing major psychiatric disorder that would preclude the ability to take part in functional assessments and the ability to give informed consent
- •3. Lack of carer, significant other or family member to support attendance at regular assessments.
- •Exclusion criteria for the surgical intervention are:
- •4. Participants on any long-term anticoagulant medication (to include aspirin, warfarin, clexane)
- •5. Any significant medical condition that would compromise the safety of anaesthesia and/ or surgery including; Q-T interval prolongation, torsades des pointes or ventricular arrhythmia
- •6. Participants not deemed to be suitable for transplant surgery (e.g. inadequate striatal volume on MRI)
- •7. Pregnancy and breastfeeding
- •Added 31/07/2019: 8. Previous immunizing event such as blood transfusion or previous transplant
- •9. Contraindications to 3T MRI (such as a fitted pacemaker)
- •10. Contraindications to PET
- •11. Any contraindication to immunosuppressive therapy
- •12. Positive blood tests for; Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), active Cytomegalovirus (CMV)infection, active Toxoplasma Gondii (Toxo G), Human T-cell lymphotropic virus type 1 (HTLV 1), serology for active treponema pallidum
- •13. Women of childbearing potential and male participants with partners of childbearing potential who will not commit to the prevention of and active monitoring for pregnancy by using a highly effective form of contraception and undertaking regular pregnancy tests whilst enrolled in the study/or on immunosuppressant
研究者
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