NCT02065778

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

4.6 years

First QC Date

February 15, 2014

Last Update Submit

October 23, 2018

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

  • Functional Independence Measure

    6 months

Study Arms (1)

Stem Cells

EXPERIMENTAL

autologous bone marrow mononuclear cell transplantation

Biological: Autologous bone marrow mononuclear cell transplantation

Interventions

Autologous bone marrow mononuclear cell transplantationBIOLOGICAL

bone marrow derived mononuclear cells are administered intrathecally in chronic stroke patients

Stem Cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males and females
  • above 18 years of age
  • diagnosed as stroke by clinical and MRI findings

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, 400071, India

Location

Related Publications (2)

  • 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.

    PMID: 21727900BACKGROUND

  • 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.

    PMID: 25126443DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Alok K Sharma, M.S., M.Ch

    Neurogen Brain and Spine Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2014

First Posted

February 19, 2014

Study Start

December 1, 2008

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

IN(1)