| CTRI Number |
CTRI/2010/091/000435 [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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Clinical study on the use of ex vivo expanded Allogenic Mesenchymal Stem Cells for Cerebral Palsy |
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Scientific Title of Study
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Clinical Study on the use of ex vivo expanded Allogenic Mesenchymal Stem Cells for Cerebral Palsy |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| ANSA/BGSG/0010/10-11 |
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 |
+91-80-25289292 |
| Fax |
+91-80-43312299 |
| 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, 1ST & 2ND Floor, 9th Main, Indiranagar, Bangalore 560 038. |
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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, -560060
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 |
Cerebral Palsy, |
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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 |
NIL |
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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 investigators discretion. However the following criteria will be considered.
- Must be more than 2 years of age and less than 15 years of age at the time of screening for inclusion in the study.
- Clinical evidence of a non-progressive motor disability due to brain dysfunction. The subjects will not have the ability to sit independently by one year of age or the ability to walk by 18 months of age.
- Willing to comply with all study procedures.
- The patients must be seizure-free or seizures adequately controlled. If there is a suspicion of seizures and EEG should be done prior to inclusion.
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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. Have complicating medical issues that would interfere with blood drawing, such as venous access so limited that success is unlikely
2. Presence of obstructive hydrocephalus.
3. Presence of progressive neurological disease.
4. Presence of known chromosomal anomaly
5. Presence of major congenital anomaly
6. Evidence of illness on planned infusion date (such as but not limited to fever >38.5, vomiting, diarrhea, wheezing, or crackles)
7. Use of immunosuppressive drugs
8. Evidence of known genetic disorder
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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 |
| After discharge, patients will have follow-up examinations to assess their clinical status and to review their current medication. 1. Clinical improvement will be defined as a decrease in the specific symptom and/or lesions. 2. Safety and tolerability, assessed by adverse events 3. Quality of life 4. Neuropyschological tests to assess the IQ in these children. 5. Appropriate tests to record Renal function tests, Liver function tests at the end of the study. |
3,6, 9, 12 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| Confirm the efficacy of allogenic mesenchymal stem cells infusion in children with cerebral palsy using patient questionnaire and standardized gross Motor Function Measures evaluation |
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) |
01/04/2010 |
| 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. 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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