- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245698
Autologous Stem Cell Therapy in Stroke
October 23, 2018 updated by: Neurogen Brain and Spine Institute
Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Stroke
The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with sub acute/chronic stroke.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maharashtra
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Navi Mumbai, Maharashtra, India, 400706
- Neurogen brain and spine institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age18 years-80 years
- diagnosed as stroke by clinical and MRI findings
Exclusion Criteria:
- presence of respiratory distress
- presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/ Hepatitis C Virus
- malignancies
- acute medical conditions such as respiratory infection, fever
- hemoglobin less than 8
- bleeding tendency
- bone marrow disorder
- left ventricular ejection fraction < 30%
- pregnancy or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stem Cell
Bone marrow mononuclear cells
|
Intrathecal autologous bone marrow mononuclear cell transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Independence Measure
Time Frame: 1 year
|
Functional Independence Measure scale assesses the patients ability to carry out activities of daily living.
At the follow up of 1 year, every patient in this study will be reevaluated on this scale.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
September 12, 2014
First Submitted That Met QC Criteria
September 17, 2014
First Posted (Estimate)
September 19, 2014
Study Record Updates
Last Update Posted (Actual)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGBSI-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
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University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
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Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
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Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
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IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
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Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
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University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
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University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
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Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on Stem cell
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China Medical University HospitalUnknownIschemia | Ischemic Stroke | Brain Ischemia | Infarction, Middle Cerebral Artery | Ischaemic Cerebral InfarctionTaiwan
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National Heart Institute, MexicoNational Center of Blood Transfusion Mexico.UnknownAcute Myocardial InfarctionMexico
-
Royan InstituteCompletedOsteoarthritisIran, Islamic Republic of
-
Northwestern UniversityTerminated
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Mongolian National University of Medical SciencesNot yet recruiting
-
Hackensack Meridian HealthActive, not recruitingDiabetes Mellitus Type 1United States
-
Royan InstituteCompletedCerebral PalsyIran, Islamic Republic of
-
Al-Azhar UniversityCompletedPremature Ovarian FailureEgypt
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Mayo ClinicUniversity of Alabama at Birmingham; University of Mississippi Medical CenterCompletedChronic Kidney Disease | Renal Artery Stenosis | Ischemic Nephropathy | Renovascular DiseaseUnited States
-
Royan InstituteCompletedOsteoarthritisIran, Islamic Republic of