Stem Cell Therapy in Traumatic Brain Injury

NCT ID: NCT02028104

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cells

autologous bone marrow mononuclear cell transplantation

Group Type EXPERIMENTAL

Autologous bone marrow mononuclear cell transplantation

Intervention Type BIOLOGICAL

bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients

Interventions

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Autologous bone marrow mononuclear cell transplantation

bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed cases of chronic traumatic brain injury
* Age above 6 months

Exclusion Criteria

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B - Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
* pregnancy
* lactation
Minimum Eligible Age

6 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurogen Brain and Spine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alok K Sharma, M.S., M.Ch

Role: PRINCIPAL_INVESTIGATOR

Neurogen Brain and Spine Institute

Locations

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Neurogen brain and spine institute

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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Lee DH, Lee JY, Oh BM, Phi JH, Kim SK, Bang MS, Kim SU, Wang KC. Functional recovery after injury of motor cortex in rats: effects of rehabilitation and stem cell transplantation in a traumatic brain injury model of cortical resection. Childs Nerv Syst. 2013 Mar;29(3):403-11. doi: 10.1007/s00381-012-1969-4. Epub 2012 Nov 24.

Reference Type BACKGROUND
PMID: 23180314 (View on PubMed)

Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11.

Reference Type BACKGROUND
PMID: 22891928 (View on PubMed)

Other Identifiers

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NGBSI-06

Identifier Type: -

Identifier Source: org_study_id

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