An open label, non randomized, uncontrolled, bio interventional, single centric, pilot study in Traumatic Brain Injury

• Conditions: Traumatic Brain Injury

• Registration Number: CTRI/2010/091/000436
• Lead Sponsor: ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)

Brief Summary

The study has been designed as an Open labelled, Non-randomized, Un-controlled, Prospective, Single center, Pilot study .After initial screening ( as per inclusion/exclusion criteria) and post recruitment, the subject will undergo all baseline tests ( as described). Subsequent to baseline tests, he/she will receive ex-vivo expanded allogeneic mesenchymal stem cells (4million cells/Kg body weight) intra-cranially (bilateral pre-coronal burr hole surgery) at a single centre in India. Source of cells: The mesenchymal stem cells would be derived from the Bone marrow of an adult healthy donor after appropriate screening and informed consent. Method of expansion: The sample would be centrifuged and the cell suspension separated using density gradient technique to isolate the mononuclear stem cells (MNCs) .From the MNC fraction, mesenchymal stem cells will be further isolated using plastic adhesion technique and expanded in vitro to obtain the required number of cells for intervention. Quality procedure: The cells would be further quality tested as per ISCT (International Society for Cellular Therapy) guidelines before release for clinical intervention.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

• 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 injury2.Hospital admission Glasgow coma score between 5 and 83.Significant Traumatic brainstem4.Altered Sensorium >1 month5.Severe cognitive impairment6.less than one month post-injury 7.
• Willing to return for follow-ups through out the duration of the study.

Exclusion Criteria

• Exclusion of patients from therapy will be under the investigator?s discretion.
• However the following criteria will be considered1.On ventilatory support2.Previous brain injury3.Significant clinical evidence of infection4.Evidence of raised ICT clinical / radiological or by monitor5.Renal disease or altered renal function as defined by serum creatinine > 1.5 mg/dL at admission6.Hepatic disease or altered liver function as defined by SGPT > 150 U/L, and/or T.
• bilirubin > 2 mg/dL at admission7.
• Cancer 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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1At 1, 3, 6 ,9 and 12 months after discharge, patients will have follow-up examinations to assess their clinical status and to review their current medication. 2Glasgow coma scale, 3PULSES profile 4Disability rating scale. 5Safety and tolerability, assessed by adverse events6Quality of life7Neurological events such as seizures, change in Glasgow coma scale (GCS), cerebral vascular accident (CVA)] 8infectious morbidity 9secondary organ injury	3,6,9,12 months

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome will be the change in the baseline and improvement (if any) in the quality of life of the patient.	3,6,9,12 months

Trial Locations

Locations (1)

BGS-GLOBAL HOSPITAL; 🇮🇳 Bangalore, KARNATAKA, India

BGS-GLOBAL HOSPITAL

🇮🇳Bangalore, KARNATAKA, India

Dr. Abhilash Bansal

Principal investigator

80-26255555

abhilashbansal@hotmail.com