Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 166 for:    stem cell stroke

Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02065778
Recruitment Status : Withdrawn
First Posted : February 19, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Biological: Autologous bone marrow mononuclear cell transplantation Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Chronic Stroke
Study Start Date : December 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: Stem Cells
autologous bone marrow mononuclear cell transplantation
Biological: Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally in chronic stroke patients




Primary Outcome Measures :
  1. Functional Independence Measure [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065778


Locations
Layout table for location information
India
Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
Investigators
Layout table for investigator information
Principal Investigator: Alok K Sharma, M.S., M.Ch Neurogen Brain and Spine Institute

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02065778     History of Changes
Other Study ID Numbers: NGBSI-08
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases