Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
1 other identifier
interventional
120
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 26, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedDecember 29, 2011
December 1, 2011
3 years
December 26, 2011
December 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
NIHSS score and functional status
3, 6 and 12 months post randomization
Study Arms (2)
Autologous bone marrow stem cell
EXPERIMENTALControl
NO INTERVENTIONInterventions
Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.
Eligibility Criteria
You may qualify if:
- Sudden onset of focal neurologic deficit or impairment of consciousness.
- CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
- Age between 30 -70 years (after amendment 18 -70 years).
- \>7 to \</=30 days passed since the onset of the qualifying event.
- Glasgow Coma Scale score of \>8 at the time of randomization, in aphasic Eye and Motor score of \>6.
- Modified Barthel Index score of 50 or less at the time of randomization.
- NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
- Patient is stable. ( normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \< 200 mg% and normal urea/electrolytes for at least 48 hours.)
You may not qualify if:
- Lacunar syndrome
- Intubation
- Posterior circulation stroke
- Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
- Inaccessibility for follow up.
- Allergy to local anaesthetic.
- Unwillingness to provide written informed consent.
- Symptom of acute myocardial infarction or acute involvement of any other organ.
- Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manipal Acunova Ltd.lead
- Ministry of Science and Technology, Indiacollaborator
Study Sites (5)
Post Graduate Institute of Medical Education and Research
Chandīgarh, Haryana, 160012, India
Armed Forces Medical College
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
Related Publications (2)
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.
PMID: 25378424DERIVEDPrasad 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.
PMID: 22960888DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2011
First Posted
December 29, 2011
Study Start
October 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 29, 2011
Record last verified: 2011-12