Autologous Stem Cell Therapy in Stroke

Stroke Clinical Trial

Official title:

Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02245698
• Other study ID #: NGBSI-11
• Status: Withdrawn
• Phase: Phase 1
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Stroke

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