ReN-009(ReN-009) - 在研适应症：亨廷顿舞蹈病_专利_临床

概要

基本信息

药物类型

干细胞疗法

别名

CTX DP、CTX cells、CTX0E03-ReN-009

+ [3]

靶点-

作用机制

细胞替代物

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床前

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 ReN-009 相关的临床试验

NCT02117635 / Completed临床2期

A Phase II Efficacy Study of Intracerebral CTX0E03 DP in Patients With Stable Paresis of the Arm Following an Ischaemic Stroke.

The primary aim of this Phase II trial is to determine whether it is sufficiently likely that CTX DP treatment at a dose level of 20 million cells improves the recovery in the use of the paretic arm in acute stroke patients to justify a subsequent larger prospectively controlled study.
This study will evaluate the safety and efficacy of intracerebral CTX DP at a dose level of 20 million cells in patients with paresis of an arm following an ischaemic middle cerebral artery (MCA) stoke. Eligible patients will have no useful function of the paretic arm a minimum of 28 days after the ischaemic stroke (a modified NIH Stroke Scale (NIHSS) Motor Arm Score of 2, 3 or 4 for the affected arm).

开始日期2014-06-01

申办/合作机构

ReNeuron Ltd.

NCT01916369 / Completed临床1期

A Phase I Ascending Dose Safety Study Of Intramuscular CTX0E03 In Patients With Lower Limb Ischaemia

The primary objective of the Phase I ascending dose trial is to investigate the safety and tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product, CTX, in patients with peripheral arterial disease (Fontaine Stage II through IV). This trial is based on independent preclinical data from a leading academic research institution that has been submitted for publication. Inclusion of patients with Fontaine Stage II is justified as these patients have a lower incidence of background events and will facilitate distinction between events which are possibly intervention-related versus spontaneous events associated with underlying advanced atherosclerosis. The trial is designed to treat 9-18 patients and evaluate safety measures over a 12 month follow-up period.

开始日期2014-04-01

申办/合作机构

ReNeuron Ltd.

100 项与 ReN-009 相关的临床结果

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100 项与 ReN-009 相关的转化医学

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100 项与 ReN-009 相关的专利（医药）

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10

项与 ReN-009 相关的文献（医药）

2018-11-01·Microbial Pathogenesis3区 · 医学

Preparation and evaluation of chitosan nanoparticles containing CtxB antigen against Vibrio cholera

3区 · 医学

Article

作者: Amani, Jafar ; Kazemi, Rohoallah ; Tabrizi, Niloufar Mirzaee ; Ebrahimzadeh, Mohammad ; Almasian, Pegah ; Nazarian, Shahram

Vibrio cholera is a Gram-negative pathogen that causes diarrheal disease. The B subunit of Chlora toxin (CtxB) is one of the most important antigens of Vibrio cholera in which mediates the attachment of the bacteria to target cells. The aim of this study was to prepare chitosan nanoparticles containing CtxB and evaluate the effect of the antigen entrapment on the immunogenicity of this antigen. For this, the pET28a vector was induced using IPTG. Recombinant CtxB protein was expressed and purified using Ni-NTA column and finally was confirmed by western blotting. Following the confirmation of the protein entrapment onto the chitosan nanoparticles, the formulation was prescribed to BALB/c mice in three groups, including oral, oral-injection and injection groups. Serum and fecal IgA and IgG were evaluated by ELISA test. Finally, challenge of immunized mice was performed using Ctx toxin and rabbit ileal loop test. Using SDS-PAGE and western blotting, the 17.5 kDa recombinant CtxB was confirmed. Size electrical charge and of nanoparticles were determined and approved by Zetasizer. Nanoparticles prescription showed 1/102400 IgG endpoint titers for injection groups and 1/1600, 1/6400 for oral, oral-injection groups respectively and Serum and fecal IgA endpoint titers showed above 1/160 in all groups. Furthermore, immunized mice were able to neutralize Ctx toxin by ileal loop test. The CtxB is a suitable immunogen of V. cholera to be incorporated in both protective and preventive vaccines. Chitosan nanoparticles improve the immune responses and it may be used as a carrier for vaccine delivery.

2016-08-01·The Lancet1区 · 医学

Human neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man study

1区 · 医学

Article

作者: McLean, John ; Smith, Wilma ; Muir, Keith W ; Santosh, Celestine ; Pollock, Kenneth ; Haig, Caroline ; Kalladka, Dheeraj ; Sinden, John ; Dunn, Laurence ; McConnachie, Alex ; Bath, Philip M

BACKGROUNDCTX0E03 is an immortalised human neural stem-cell line from which a drug product (CTX-DP) was developed for allogeneic therapy. Dose-dependent improvement in sensorimotor function in rats implanted with CTX-DP 4 weeks after middle cerebral artery occlusion stroke prompted investigation of the safety and tolerability of this treatment in stroke patients.METHODSWe did an open-label, single-site, dose-escalation study. Men aged 60 years or older with stable disability (National Institutes of Health Stroke Scale [NIHSS] score ≥6 and modified Rankin Scale score 2-4) 6-60 months after ischaemic stroke were implanted with single doses of 2 million, 5 million, 10 million, or 20 million cells by stereotactic ipsilateral putamen injection. Clinical and brain imaging data were collected over 2 years. The primary endpoint was safety (adverse events and neurological change). This trial is registered with ClinicalTrials.gov, number NCT01151124.FINDINGS13 men were recruited between September, 2010, and January, 2013, of whom 11 (mean age 69 years, range 60-82) received CTX-DP. Median NIHSS score before implantation was 7 (IQR 6-8) and the mean time from stroke was 29 (SD 14) months. Three men had subcortical infarcts only and seven had right-hemisphere infarcts. No immunological or cell-related adverse events were seen. Other adverse events were related to the procedure or comorbidities. Hyperintensity around the injection tracts on T2-weighted fluid-attenuation inversion recovery MRI was seen in five patients. At 2 years, improvement in NIHSS score ranged from 0 to 5 (median 2) points.INTERPRETATIONSingle intracerebral doses of CTX-DP up to 20 million cells induced no adverse events and were associated with improved neurological function. Our observations support further investigation of CTX-DP in stroke patients.FUNDINGReNeuron Limited.

2015-06-15·Chemical Research in Toxicology3区 · 医学

Synthetic Ciguatoxin CTX 3C Induces a Rapid Imbalance in Neuronal Excitability

3区 · 医学

Article

作者: Vieytes, Mercedes R. ; Vale, Carmen ; Yamashita, Shuji ; Hirama, Masahiro ; Botana, Luis M. ; Rubiolo, Juan Andrés ; Martín, Victor

Ciguatera is a human global disease caused by the consumption of contaminated fish that have accumulated ciguatoxins (CTXs), sodium channel activator toxins. Symptoms of ciguatera include neurological alterations such as paraesthesiae, dysaesthesiae, depression, and heightened nociperception, among others. An important issue to understand these long-term neurological alterations is to establish the role that changes in activity produced by CTX 3C represent to neurons. Here, the effects of synthetic ciguatoxin CTX 3C on membrane potential, spontaneous spiking, and properties of synaptic transmission in cultured cortical neurons of 11-18 days in vitro (DIV) were evaluated using electrophysiological approaches. CTX 3C induced a large depolarization that decreased neuronal firing and caused a rapid inward tonic current that was primarily GABAergic. Moreover, the toxin enhanced the amplitude of miniature postsynaptic inhibitory currents (mIPSCs), whereas it decreased the amplitude of miniature postsynaptic excitatory currents (mEPSCs). The frequency of mIPSCs increased, whereas the frequency of mEPSCs remained unaltered. We describe, for the first time, that a rapid membrane depolarization caused by CTX 3C in cortical neurons activates mechanisms that tend to suppress electrical activity by shifting the balance between excitatory and inhibitory synaptic transmission toward inhibition. Indeed, these results suggest that the acute effects of CTX on synaptic transmission could underlie some of the neurological symptoms caused by ciguatera in humans.

100 项与 ReN-009 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
下肢缺血	临床2期	英国	ReNeuron Ltd.	2014-04-01
外周动脉疾病	临床2期	英国	ReNeuron Ltd.	2014-04-01
亨廷顿舞蹈病	临床前	英国	ReNeuron Group Plc	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


PHOENIX-GC (ASCO_GI2019)	临床3期	腹膜癌 \| 胃癌	-	Surgery + IP floxuridine/leucovorin CTX	(願遞壓齋積廠壓網顧獵) = 選構範製憲憲壓構範顧窪鹽廠觸觸夢繭顧衊糧 (鹽艱鹹網膚遞醖壓繭鬱 ) 更多	-	2019-01-29
				CTX alone	(願遞壓齋積廠壓網顧獵) = 積餘構築積鏇願構廠襯窪鹽廠觸觸夢繭顧衊糧 (鹽艱鹹網膚遞醖壓繭鬱 ) 更多
ASCO2009	临床2期	局部晚期胰腺腺癌	80	Concurrent chemoradiotherapy (CRT) group	(齋遞窪窪淵艱觸艱廠夢) = 範獵築網範艱積願夢獵糧廠願簾觸醖衊鏇願淵 (淵艱夢鏇範鹹餘鬱網夢 ) 更多	积极	2009-05-20
				Chemotherapy alone (CTX) group	(齋遞窪窪淵艱觸艱廠夢) = 簾繭築鑰顧壓鏇鬱選鹹糧廠願簾觸醖衊鏇願淵 (淵艱夢鏇範鹹餘鬱網夢 ) 更多