Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Address
Phone
Fax
Email
Details Contact Person Scientific Query
Name
Address
Phone
Fax
Email
Details Contact Person Public Query
Name
Address
Phone
Fax
Email
Source of Monetary or Material Support
Anupam Hospital (In house funded Hospital Trial)
Primary Sponsor
Name
Address
Type of Sponsor
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Contact Person
Name of Site
Site Address
Phone/Fax/Email
Dr Himanshu Bansal
Anupam Hospital
Anupam Hospital,
2nd floor
Near Indian Bank
Rudrapur (next to Pantnagar University)
Uttarakhand, 263153, India Udham Singh Nagar
9634501234
hbansal@drhbf.org
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Committee for Stem cell Research and therapy
Approved
Regulatory Clearance Status from DCGI
Status
Health Condition / Problems Studied
Health Type
Condition
Patients
For reversal of Brain death due to traumatic brain injury having diffuse axonal injury.
Intervention / Comparator Agent
Type
Name
Details
Intervention
1. Bioactive peptides (Bioquantine 5 percent solution via intrathecal pump
2. Intrathecal stem cells
3. Median nerve stimulation (MNS)
4. Intravenous and transcranial laser stimulation
1. Bioactive peptides (Bioquantine 5 percent solution‟ (Mfg by: Bioquark Inc Philadelphia USA) via intrathecal pump
2. Intrathecal stem cells
3. Median nerve stimulation (MNS)
4. Intravenous and transcranial laser stimulation
Inclusion Criteria
Age From
Age To
Gender
Details
ExclusionCriteria
Details
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
Any evidence of reversal of brain death as noted in clinical examination or EEG
15 days
Secondary Outcome
Outcome
TimePoints
Evaluations of clinical laboratory tests including Cerebrospinal fluid (CSF) analysis and MRI
15 days
Pulse, O2 saturation, blood pressure and respiration will serve to monitor autonomic nervous system mediated cardiovascular or respiratory modulation, Electrocardiogram (ECG) monitoring to identify cardiac-related side effects, including heart rhythm changes, irregular heartbeat, heart palpitations