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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02245698
Other study ID # NGBSI-11
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 2008
Est. completion date December 2018

Study information

Verified date October 2018
Source Neurogen Brain and Spine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Stem cell
Intrathecal autologous bone marrow mononuclear cell transplantation

Locations

Country Name City State
India Neurogen brain and spine institute Navi Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Independence Measure 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
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