Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke|
- Barthel index score [ Time Frame: six month post randomization ] [ Designated as safety issue: Yes ]The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization.
- NIHSS score and functional status [ Time Frame: 3, 6 and 12 months post randomization ] [ Designated as safety issue: Yes ]
- NIHSS score at 6 months and one year post randomization.
- And degree of handicap as measured by Modified Ranking scale administered at 3, 6 and 12 months post randomization and functional status at 6 months and 12 months post randomization
|Study Start Date:||October 2008|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Autologous bone marrow stem cell||
Biological: Autologous bone marrow stem cell
Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.
|No Intervention: Control|
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 moderae severity in sable condition will be entered into the study after informed consent. Both arms will receive 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 at DaY 7 ± days, Day 90(-7 days to +14 days), Day 180(-7 days to +28 days)and Day 365 (-7 days to + 28 days). A number of safety and efficacy variables will be measured. This phase 2 study will aim to determine dose response gradient of stem cell therapy and to explore if results have a favourable risk to benefit ratio to justify a phase 3 study. This will be the first human trial to determine and compare favourable and unfavourable effects of bone marrow mononuclear cells(mainly CD34) in acute ischamic stroke and also the first multi-centric study with potential to achieve a reasonable sample size in a relatively short time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501773
|All India Institute of Medical Sciences|
|New Delhi, Delhi, India, 110029|
|Army Hospital (R & R Hospital)|
|New Delhi, Delhi, India|
|Post Graduate Institute of Medical Education and Research|
|Chandigarh, Haryana, India, 160012|
|Armed Forces Medical College|
|Pune, Maharastra, India, 411040|
|Sanjay Gandhi Postgraduate Institute of Medical Sciences|
|Lucknow, UttarPradesh, India, 226014|
|Principal Investigator:||Dr. Kameshwar Prasad, MBBS, MD||All India Institute of Medical Sciences, New Delhi|
|Principal Investigator:||Dr. Usha Kant Misra, MBBS, MD, DM||Sanjay Gandhi Postgraduate Institute of Medical Sciences|
|Principal Investigator:||Dr. R.S Sarkar||Armed Forces Medical College|
|Principal Investigator:||Dr. Sudesh Kumar Prabhakar, MBBS, MD, DM||Post Graduate Institute of Medical Education and Research|
|Principal Investigator:||Dr. Sharat Joshi, MBBS,MD, DM||Army R & R Hospital|