跳至主要内容
临床试验/CTRI/2013/10/004105
CTRI/2013/10/004105进行中(未招募)2 期

A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of stroke.

Arivind Bagul0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Should suffer from stroke due to cerebral infarct or haemorrhage or accelerated hyper tension.
  • 2.Willingness to undergo Autologous Stem Cell Therapy
  • 3.Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
  • 4.Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

排除标准

  • 1.Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
  • 2.History of life threatening allergic or immune-mediated reaction.
  • 3. Haemodynamically unstable subjects.
  • 4.Subjects suffering from peripheral muscular dystrophy.
  • 5.Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
  • 6.Positive test results for Hepatitis A and Hepatitis B or C.
  • 7.Alcohol and / or drug abuse/ dependence.
  • 8.Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
  • 9.Neurological disease caused by autoimmune or genetic cause.

研究者

发起方
Arivind Bagul

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