| CTRI Number |
CTRI/2010/091/000436 [Registered on: 14/09/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
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An open label, non randomized, uncontrolled, bio interventional, single centric, pilot study in Traumatic Brain Injury |
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Scientific Title of Study
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A Pilot study on the use of Allogenic Mesenchymal Stem Cells in Traumatic Brain Injury |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| BGS/021/09 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. N.K. VENKATARAMANA, |
| Designation |
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| Affiliation |
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| Address |
Director, Advanced Neuro-science Institute Vice-Chairman, BGS-Global Hospital,
BGS Health & Education City, # 67, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
+080-25289292 |
| Fax |
+080-43312299 |
| Email |
drnkvr@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Satish Totey ;President & CEO |
| Designation |
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| Affiliation |
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| Address |
Advanced Neuro-Science Allies Pvt. Ltd #560, Bhargavi, 9th ?A? Main,
Indiranagar,
Bangalore
KARNATAKA
560038
India |
| Phone |
+91-080-43312222 |
| Fax |
+91-080-43312299 |
| Email |
satishtotey@ansaresearch.com |
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Details of Contact Person
Public Query
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| Name |
Mrs. Vijayalakshmi |
| Designation |
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| Affiliation |
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| Address |
Advanced Neuro-Science Allies Pvt. Ltd #560, Bhargavi, 9th "A" Main,
Indiranagar,
Bangalore
KARNATAKA
560038
India |
| Phone |
+91-80-43312222 |
| Fax |
+91-80-43312299 |
| Email |
viji@ansaresearch.com |
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Source of Monetary or Material Support
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| ADVANCED NEURO-SCIENCE ALLIES PVT LTD, #560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore 560 038, Karnataka (INDIA) |
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Primary Sponsor
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| Name |
ADVANCED NEURO-SCIENCE ALLIES PVT. LTD
#560, Bhargavi, 9th "A" Main, Indiranagar,
Bangalore-560 038
Karnataka (INDIA)
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Abhilash Bansal |
BGS-GLOBAL HOSPITAL |
BGS Health & Education City,#67, Uttarahalli Road, Kengeri,-560038
Bangalore
KARNATAKA |
+91-80-26255555
abhilashbansal@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS Global Hospital BGS Health & Education City, # 67, Uttarahalli Road, Kengeri Bangalore-560 060 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Traumatic Brain Injury, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
bilateral precoronal burr hole |
4 million cells/ kg body weight |
| Comparator Agent |
NIL |
Not applicable |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
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.
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| ExclusionCriteria |
| Details |
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
7. 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. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 1 At 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.
2 Glasgow coma scale,
3 PULSES profile
4 Disability rating scale.
5 Safety and tolerability, assessed by adverse events
6 Quality of life
7 Neurological events such as seizures, change in Glasgow coma scale (GCS), cerebral vascular accident (CVA)]
8 infectious morbidity
9 secondary organ injury |
3,6,9,12 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| 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 |
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Target Sample Size
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Total Sample Size="15"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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.
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