CTRI/2010/091/000436招募中未知
A Pilot study on the use of Allogenic Mesenchymal Stem Cells in Traumatic Brain Injury
ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 15
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
- •Inclusion of patients for therapy will be under the investigator's discretion. However the following criteria will be considered.
- •1.More than 18 years old on the day of injury
- •2.Hospital admission Glasgow coma score between 5 and 8
- •3.Significant Traumatic brainstem
- •4.Altered Sensorium >1 month
- •5.Severe cognitive impairment
- •6.less than one month post-injury
- •7. Willing to return for follow-ups through out the duration of the study.
排除标准
- •Exclusion of patients from therapy will be under the investigator?s discretion. However the following criteria will be considered
- •1.On ventilatory support
- •2.Previous brain injury
- •3.Significant clinical evidence of infection
- •4.Evidence of raised ICT clinical / radiological or by monitor
- •5.Renal disease or altered renal function as defined by serum creatinine > 1.5 mg/dL at admission
- •6.Hepatic disease or altered liver function as defined by SGPT > 150 U/L, and/or T. bilirubin > 2 mg/dL at admission
- •8.Hemodynamic instability at the time of consent defined as ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age
- •9.Uncorrected coagulopathy at the time of consent
- •10.Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FIO2 ratio < 250 associated with the mechanism or injury
- •11.Solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging
- •12.any otherinjury as diagnosed by CT or MR imaging or by clinical findings.
- •13.Persistent hypoxia defined as SaO2 < 94% for > 30 minutes
- •14.Positive urine pregnancy test ( in case of females)
- •15.Participation in any other intervention study
- •16.Unwillingness to return for follow-up visits
- •17.Positivity for HIV, HBV, HCV,VDRL.
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