search
Back to results

Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

Primary Purpose

Cerebrovascular Accident

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell transplantation
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cells

Arm Description

autologous bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

Functional Independence Measure

Secondary Outcome Measures

Full Information

First Posted
February 15, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02065778
Brief Title
Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke
Official Title
A Clinical Study of Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cells
Arm Type
Experimental
Arm Description
autologous bone marrow mononuclear cell transplantation
Intervention Type
Biological
Intervention Name(s)
Autologous bone marrow mononuclear cell transplantation
Intervention Description
bone marrow derived mononuclear cells are administered intrathecally in chronic stroke patients
Primary Outcome Measure Information:
Title
Functional Independence Measure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok K Sharma, M.S., M.Ch
Organizational Affiliation
Neurogen Brain and Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
21727900
Citation
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.
Results Reference
background
PubMed Identifier
25126443
Citation
Sharma A, Sane H, Gokulchandran N, Khopkar D, Paranjape A, Sundaram J, Gandhi S, Badhe P. Autologous bone marrow mononuclear cells intrathecal transplantation in chronic stroke. Stroke Res Treat. 2014;2014:234095. doi: 10.1155/2014/234095. Epub 2014 Jul 8.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

We'll reach out to this number within 24 hrs