EUCTR2012-003482-18-GB进行中（未招募）1 期
A Phase II Efficacy Study of Intracerebral CTX0E03 DP In Patients with Stable Paresis of the Arm Following an Ischaemic Stroke. - PISCES II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ReNeuron Ltd
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Written informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to paresis of the affected arm.
- •2.Supratentorial ischaemic stroke.
- •3.Male or female.
- •4.Age 40 years or more.
- •5.Stroke, at time of consent, satisfying the following criteria:
- •Modified NIH Stroke Scale (NIHSS) Motor Arm Score of 2 (some effort against gravity),3 (no movement against gravity) or 4 (no movement) for the paretic arm post ischaemic stroke at visit 1 and 2.
- •Clinical diagnosis of stroke confirmed by physician using neuro-imaging (computerised tomography or magnetic resonance imaging).
- •A Score of 0 or 1 for test 2 of the Action Research Arm Test (Grasp a 2.5 cm3 block and move it from the starting position to the target end position) at visit 1 and 2 post-stroke using the affected arm.
- •6.Ability to comprehend verbal commands.
- •7.Eligible for neurosurgery, including appropriate anatomical target for cell implantation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1.Prior history of stroke resulting in permanent moderate to severe disability (i.e. Rankin Scale greater than 2) (other than the presenting ischaemic stroke).
- •2.Stroke due to haemorrhage.
- •3.History of neurological or other disease resulting in significant functional impairment of the paretic arm impairing potential ability to pick up, lift and place a 2.5 cm3 block (e.g. Parkinson’s disease, motor neuron disease, arthritis, Dupuytren’s contracture or fixed anatomical abnormality).
- •4.Any contraindications to MRI including presence of a cardiac pacemaker (excluding MR-conditional cardiac pacemaker), metal fragments in eye etc.
- •5.Uncontrolled blood pressure defined as systolic blood pressure =180 mm Hg or diastolic blood pressure =110 mm Hg (patients are only to be excluded if an initial value exceeding these limits is repeated on retesting over several days).
- •6.Patient with a severe comorbid disorder, not expected to survive more than 12 months.
- •7.Acute cardiovascular events other than the presenting ischaemic stroke (e.g. myocardial infarction, recent coronary intervention for symptomatic cardiac disease) considered by the Investigator or the anaesthetist responsible for the patient to place the patient at increased anaesthetic risk, 3 months prior to planned injection of CTX0E03 DP.
- •8.History of malignant disease, (except for non-melanoma skin cancer) within the previous 5 years or any history of malignant brain tumours or brain metastasis.
- •9.Current treatment with tamoxifen.
- •10.Patients taking valproate drugs for any indication in whom it is not considered appropriate to discontinue the valproate for a period of one week prior and four weeks post neurosurgery. Patients in whom valproate is switched to an alternative agent during this period may be included.
- •11.Requirement for antiplatelets and/or anticoagulants including heparin, warfarin or other anticoagulants/ medication that cannot be interrupted to allow surgery.
- •12.Requirement for intermittent (stop/start date from 1-month prior-to and 3 month post- CTX0E03 DP administration) use of oral antispasticity medications (oral antispasticity medications are acceptable if they have been taken regularly for at least one month prior to CTX0E03 DP administration).
- •13.A history of uncontolled diabetes e.g. history of hypoglycaemic or hyperglycaemic events requiring hospital admission over previous 6 months.
- •14.Females of childbearing potential (FOCBP) (or within 2 years of last menstrual cycle) must have a confirmed negative pregnancy test at time of treatment and agree to use two reliable methods of contraception (e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom) for the duration of this study.
- •15.Sexually active males with partners who are FOCBP must be willing to use a reliable method of contraception (e.g. barrier and spermicide or as described above) for the duration of this study.
- •16.Considered unlikely to be able to attend for all follow-up visits.
- •17.Organ transplant recipient.
- •18.In the opinion of the Investigator, sustained consumption of alcohol or drugs at a level likely to be injurious to health
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