search
Back to results

Autologous Stem Cell Therapy in Stroke

Primary Purpose

Stroke

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Withdrawn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

About this trial

This is an interventional treatment trial for Stroke focused on measuring Chronic Stroke, Subacute stroke, Autologous Bone Marrow Mononuclear Cell therapy, Stem cell

Eligibility Criteria

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

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

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell

Arm Description

Bone marrow mononuclear cells

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02245698
Brief Title
Autologous Stem Cell Therapy in Stroke
Official Title
Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in 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Withdrawn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
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

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 sub acute/chronic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Chronic Stroke, Subacute stroke, Autologous Bone Marrow Mononuclear Cell therapy, Stem cell

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 Cell
Arm Type
Experimental
Arm Description
Bone marrow mononuclear cells
Intervention Type
Biological
Intervention Name(s)
Stem cell
Intervention Description
Intrathecal autologous bone marrow mononuclear cell transplantation
Primary Outcome Measure Information:
Title
Functional Independence Measure
Description
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.
Time Frame
1 year

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: 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
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Navi Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400706
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Autologous Stem Cell Therapy in Stroke

We'll reach out to this number within 24 hrs