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

+ [2]

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-

登录后查看时间轴

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

登录后查看更多信息

100 项与 ReN-009 相关的转化医学

登录后查看更多信息

100 项与 ReN-009 相关的专利（医药）

登录后查看更多信息

9

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: Kazemi, Rohoallah ; Amani, Jafar ; 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.

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

Chronic Ciguatoxin Treatment Induces Synaptic Scaling through Voltage Gated Sodium Channels in Cortical Neurons

3区 · 医学

Article

作者: Shuji Yamashita ; Maria Roel ; Mercedes R. Vieytes ; Masahiro Hirama ; Carmen Vale ; Víctor Martín ; Luís M. Botana ; Juan A. Rubiolo

Ciguatoxins are sodium channels activators that cause ciguatera, one of the most widespread nonbacterial forms of food poisoning, which presents with long-term neurological alterations. In central neurons, chronic perturbations in activity induce homeostatic synaptic mechanisms that adjust the strength of excitatory synapses and modulate glutamate receptor expression in order to stabilize the overall activity. Immediate early genes, such as Arc and Egr1, are induced in response to activity changes and underlie the trafficking of glutamate receptors during neuronal homeostasis. To better understand the long lasting neurological consequences of ciguatera, it is important to establish the role that chronic changes in activity produced by ciguatoxins represent to central neurons. Here, the effect of a 30 min exposure of 10-13 days in vitro (DIV) cortical neurons to the synthetic ciguatoxin CTX 3C on Arc and Egr1 expression was evaluated using real-time polymerase chain reaction approaches. Since the toxin increased the mRNA levels of both Arc and Egr1, the effect of CTX 3C in NaV channels, membrane potential, firing activity, miniature excitatory postsynaptic currents (mEPSCs), and glutamate receptors expression in cortical neurons after a 24 h exposure was evaluated using electrophysiological and western blot approaches. The data presented here show that CTX 3C induced an upregulation of Arc and Egr1 that was prevented by previous coincubation of the neurons with the NaV channel blocker tetrodotoxin. In addition, chronic CTX 3C caused a concentration-dependent shift in the activation voltage of NaV channels to more negative potentials and produced membrane potential depolarization. Moreover, 24 h treatment of cortical neurons with 5 nM CTX 3C decreased neuronal firing and induced synaptic scaling mechanisms, as evidenced by a decrease in the amplitude of mEPSCs and downregulation in the protein level of glutamate receptors that was also prevented by tetrodotoxin. These findings identify an unanticipated role for ciguatoxin in the regulation of homeostatic plasticity in central neurons involving NaV channels and raise the possibility that some of the neurological symptoms of ciguatera might be explained by these compensatory mechanisms.

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

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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	(衊憲蓋艱齋築築積蓋範) = 淵獵衊糧鏇構鏇獵艱齋醖遞築廠獵積鬱範觸齋 (鑰觸範製簾齋膚衊願襯 ) 更多	-	2019-01-29
				CTX alone	(衊憲蓋艱齋築築積蓋範) = 遞鑰獵鹹鑰選範鏇醖製醖遞築廠獵積鬱範觸齋 (鑰觸範製簾齋膚衊願襯 ) 更多
ASCO2009	临床2期	局部晚期胰腺腺癌	80	Concurrent chemoradiotherapy (CRT) group	(獵獵選築膚範積憲夢製) = 壓夢範壓製鏇顧觸糧窪蓋艱範窪簾襯範襯衊願 (艱繭醖願夢觸壓築構製 ) 更多	积极	2009-05-20
				Chemotherapy alone (CTX) group	(獵獵選築膚範積憲夢製) = 鑰醖夢憲獵壓顧獵齋顧蓋艱範窪簾襯範襯衊願 (艱繭醖願夢觸壓築構製 ) 更多