跳至主要内容
临床试验/CTRI/2011/091/000159
CTRI/2011/091/000159招募中2 期

A clinical trial to study the safety and efficacy of Bone marrow derived Autologous stem cells for the treatment of cerebral palsy in subjects above 15 years.

Chaitanya Stem Cell Center0 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
招募中
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 cerebral palsy due to prenatal and postnatal cause.
  • 2. Willingness to undergoing Bone marrow derived 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
Chaitanya Stem Cell Center

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