Cerebrovascular Accident Clinical Trial
Official title:
A Clinical Study of Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Chronic Stroke
| NCT number | NCT02065778 |
| Other study ID # | NGBSI-08 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | December 2008 |
| Est. completion date | January 2014 |
| Verified date | October 2018 |
| Source | Neurogen Brain and Spine Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with chronic stroke.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2014 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - males and females - above 18 years of age - 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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Neurogen brain and spine institute | Mumbai | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Neurogen Brain and Spine Institute |
India,
Borlongan CV. Bone marrow stem cell mobilization in stroke: a 'bonehead' may be good after all! Leukemia. 2011 Nov;25(11):1674-86. doi: 10.1038/leu.2011.167. Epub 2011 Jul 5. Review. — View Citation
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| Primary | Functional Independence Measure | 6 months |
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