Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and Technology, India | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous bone marrow stem cell | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow stem cell | Biological | Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel index score | The primary efficacy outcome is difference between the two groups in the modified Barthel index score at six month post randomization. | six month post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS score and functional status |
| 3, 6 and 12 months post randomization |
Not provided
Inclusion Criteria:
Exclusion Criteria: -
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Kameshwar Prasad, MBBS, MD | All India Institute of Medical Sciences | 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, Chandigarh | Principal Investigator |
| Dr. Sharat Joshi, MBBS,MD, DM | Army R & R Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education and Research | Chandīgarh | Haryana | 160012 | India | ||
| Armed Forces Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25378424 | Derived | Prasad K, Sharma A, Garg A, Mohanty S, Bhatnagar S, Johri S, Singh KK, Nair V, Sarkar RS, Gorthi SP, Hassan KM, Prabhakar S, Marwaha N, Khandelwal N, Misra UK, Kalita J, Nityanand S; InveST Study Group. Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: a multicentric, randomized trial. Stroke. 2014 Dec;45(12):3618-24. doi: 10.1161/STROKEAHA.114.007028. Epub 2014 Nov 6. | |
| 22960888 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pune |
| Maharashtra |
| 411040 |
| India |
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Army Hospital (R & R Hospital) | New Delhi | National Capital Territory of Delhi | India |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | Uttar Pradesh | 226014 | India |
| Derived |
| Prasad K, Mohanty S, Bhatia R, Srivastava MV, Garg A, Srivastava A, Goyal V, Tripathi M, Kumar A, Bal C, Vij A, Mishra NK. Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: a pilot study. Indian J Med Res. 2012 Aug;136(2):221-8. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |