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CTRI Number  CTRI/2008/091/000046 [Registered on: 10/06/2008]
Last Modified On: 10/11/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Stem Cell Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
Stem cells therapy for patients with acute ischemic stroke. 
Scientific Title of Study
Modification(s)  
Intravenous autologous bone marrow derived stem cells therapy for patients with acute ischemic stroke: A multi-institutional project. 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Kameshwar Prasad 
Designation   
Affiliation   
Address  Department of Neurology, Room No- 704, C.N Centre, Department of Neurology, AIIMS,

New Delhi
DELHI
110029
India 
Phone  011-26588979  
Fax  011-26588979  
Email  drkameshwarprasad@yahoo.co.in  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Prof Kameshwar Prasad 
Designation   
Affiliation   
Address  Department of Neurology, Room No- 704, C.N Centre, Department of Neurology, AIIMS,

New Delhi
DELHI
110029
India 
Phone  011-26588979  
Fax  011-26588979  
Email  drkameshwarprasad@yahoo.co.in  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Kameshwar Prasad 
Designation   
Affiliation   
Address  Department of Neurology, Room No- 704, C.N Centre, Department of Neurology, AIIMS,

New Delhi
DELHI
110029
India 
Phone  011-26588979  
Fax  011-26588979  
Email  drkameshwarprasad@yahoo.co.in  
 
Source of Monetary or Material Support
Modification(s)  
Department of Biotechnology, Ministry of Science and Technology, Government of India 
Department of Biotechnology, Ministry of Science and Technology, Government of India. [Delete]  
 
Primary Sponsor
Modification(s)  
Name  Department of Biotechnology Ministry of Science and Technology Government of India New Delhi 
Address  Lodi Road, CGO complex, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Kameshwar Prasad  All India Institute of Medical Sciences, New Delhi  Room No 704, 7th Floor, C.N Centre, Department of Neurolgogy, AIIMS,-110029
New Delhi
DELHI 
01126588979
011-26588979
kameshwarprasad@hotmail.com 
Col. (Dr) S.P Gorthi  Armed Forces Medical College Hospital, Pune  Department of Internal Medicine, AFMC Pune,,-411040
Pune
MAHARASHTRA 
020-26306011
020-26810986
pgorthi2002@yahoo.co.in 
Col. (Dr.) K.K. Singh   Army Hospital (Research & Referral), New Delhi  Delhi Cantt, New Delhi,-
New Delhi
DELHI 
01123092562

drkarni_singh@yahoo.co.in 
Dr. S. Prabhakar  Post Graduate Institute of Medical Education and Research  PGIMER, Chandigarh,-160012
Chandigarh
CHANDIGARH 
01722756691
01722744401
sudesh@prabhakars.com 
Dr U.K Mishra  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Raebareli Road, Lucknow,-226014
Lucknow
UTTAR PRADESH 
05222668004
05222668017
ukmisra@sushrut.sgpgi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
Hospital Ethics Committee, Army Hospital (Research & Referral  Approved 
Institutional Ethics Committee, AFMC  Approved 
Institutional Ethics Committee, SGPGI  Approved 
Institutional Ethics Committee,PGI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute ischemic stroke in MCA/ACA territory,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intravenous injection of bone marrow mononuclear /stem cells  at a dose of 30 to 500 million 
Comparator Agent  Standard treatment  Nil 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Sudden onset of focal neurologic deficit or impairment of consciousness, 2. Computerized tomographic or MRI scan of the head showing no haematoma, and relevant lesions within the MCA and ACA territory. 3. Age between 18 and 70 years 4. Seven days or more but less than 30 days has passed since the onset of the qualifying event, 5. Glasgow Coma Scale score of above 8 at the time of randomization (Appendix 15), in aphasic Eye and Motor score of more than 6, 6. Modified Barthel index score of 50 or less at the time of randomization (Appendix 8). 7. NIHSS score of 7 or more points and inability to walk unaided or raise upper limb by 900 (Appendix 17) 8. Patient is stable: A patient will be defined as stable when he has normal respiration, is afebrile, has BP less than mean arterial pressure of 125mm Hg (but no hypotension defined as systolic BP <90mmHg), has fasting venous blood sugar level less than 200mg% and normal urea/electrolytes for at least 48 hours. 
 
ExclusionCriteria 
Details  1. Lacunar syndrome 2. Intubation 3. Posterior Circulation Stroke 4. Co-morbidity likely to limit survival to less than three years e.g. malignant diseases, hepatic or renal failure 5. Pre-stroke disability leading to dependence on others for activities of daily living, 6. Inaccessibility for follow-up 7. Allergy to local anaesthetic 8. Unwillingness to provide written informed consent by self or assent by next of kin. 9. Symptom of Acute myocardial infarction or acute involvement of any other organ. 10. Pregnancy 11. HIV positive. 12. Patient is a part of any other trial. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference between the two groups in the Modified Barthel index score  At 180 (-7 to + 28 days) days post-randomisation 
 
Secondary Outcome  
Outcome  TimePoints 
NIHSS score   At 180 (-7 to + 28 Days) Days and 365 (-7 to +28 Days) Days post-randomisation 
Modified Rankin scale  At 180 (-7 to + 28 Days) Days and 365 (-7 to +28 Days) Days post-randomisation 
Functional status   At 180 (-7 to +28 Days) Days and 365 (-7 to +28 Days) Days post-randomization  
 
Target Sample Size   Total Sample Size="120"
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" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details
Modification(s)  
Stroke. 2014 Nov 6. pii: STROKEAHA.114.007028. [Epub ahead of print] Intravenous Autologous Bone Marrow Mononuclear Stem Cell Therapy for Ischemic Stroke: A Multicentric, Randomized Trial. Prasad K1, Sharma A2, Garg A2, Mohanty S2, Bhatnagar S2, Johri S2, Singh KK2, Nair V2, Sarkar RS2, Gorthi SP2, Hassan KM2, Prabhakar S2, Marwaha N2, Khandelwal N2, Misra UK2, Kalita J2, Nityanand S2. 
Brief Summary   The project is a multi-centric initiative to study the safety, feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells (BMMC) in patients with acute ischaemic stroke. This phase of study is visualized as phase 2 study and will aim to determine the dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for stem cell therapy in patients with acute ischaemic stroke. This phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells (BMMC arm); and second control arm. Patients with acute ischaemic stroke between 7-30 days after onset with moderate severity in stable condition will be entered into the study after informed consent. Both arms will receive the standard treatment but BMMC arm will, in addition, have bone marrow aspiration and receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of randomisation and all patients will be followed on days 1-7, and weeks 12-13, 24-25, and 52. A number of safety and efficacy variables will be measured. This phase 2 study will aim to determine the dose response gradient of stem cell therapy and to explore if the results have a favorable risk to benefit ratio to justify a phase 3 study. In the beginning, five centers will initiate the study, but more may join later, if they fulfill certain well-defined eligibility criteria. This will be the first human trial to determine and compare the favorable and unfavorable effects of bone marrow mononuclear cells (mainly CD34) in acute ischaemic Stroke, and also the first multi-centric study with the potential to achieve a reasonable sample size in a relatively short time.  
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