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WithdrawnNCT02065778Updated Oct 25, 2018

Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

A Phase 1 interventional study of Autologous bone marrow mononuclear cell transplantation in Cerebrovascular Accident, sponsored by Neurogen Brain and Spine Institute. Withdrawn at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by Neurogen Brain and Spine Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebrovascular Accident

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

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Lead sponsor

Neurogen Brain and Spine Institute is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Stem Cells

    autologous bone marrow mononuclear cell transplantation

    Biological: Autologous bone marrow mononuclear cell transplantation

Interventions

  • BiologicalAutologous bone marrow mononuclear cell transplantation

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

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What researchers measure

Primary outcomes

  1. Functional Independence Measure

    Time frame: 6 months

07

Study locations

1 site
  • Neurogen brain and spine institute
    Mumbai, Maharashtra 400071, India
08

References and documents

Publications

  • 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. PubMed 21727900 ↗
  • 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. PubMed 25126443 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02065778
Lead sponsor
Neurogen Brain and Spine Institute
Responsible party
Sponsor
First posted
Feb 19, 2014
Start date
Dec 2008
Primary completion
Jul 2013
Completion
Jan 2014
Last update
Oct 25, 2018

Study contacts

Alok K Sharma, M.S., M.Ch
principal investigator · Neurogen Brain and Spine Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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