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Intrathecal Stem Cells in Brain Injury (ISC)

Primary Purpose

Hypoxia-Ischemia, Cerebral, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Intrathecal Autologous Stem Cells
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia-Ischemia, Cerebral focused on measuring Hypoxia, Ischemia, Brain, Children, Cerebral Palsy

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with hypoxic/ischemic brain injury, with an between 1 month and 18 years, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours.

Exclusion Criteria:

  • Patients with neurodegenerative or autoimmune diseases.
  • Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure.
  • Patients who do not sign the informed consent form.

Elimination Criteria

  • Patients with severe meningeal abnormalities at the time of procedure.
  • Patients who did not attend subsequent assessments 30 and 180 days after the procedure.
  • Patients who die from causes related to neurological disease within 180 days after procedure.
  • Patients who are diagnosed with neurodegenerative or autoimmune diseases after the procedure.
  • Patients who do not bear the proper stimulation process with Granulocyte Colony Stimulating Factor (G-CSF), either by misapplication, lack thereof, or severe adverse drug reaction.
  • Patients choosing to leave the study.

Sites / Locations

  • Hospital Universitario Dr. Jose E. Gonzalez

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Children whom will receive intrathecal autologous stem cells

Outcomes

Primary Outcome Measures

Score of "Battelle Developmental Inventory"

Secondary Outcome Measures

Score of "Battelle Developmental Inventory"

Full Information

First Posted
November 24, 2009
Last Updated
January 25, 2011
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT01019733
Brief Title
Intrathecal Stem Cells in Brain Injury
Acronym
ISC
Official Title
Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic evolution of the pediatric patients with hypoxic/ischemic brain injury.
Detailed Description
There is accumulating evidence that shows that the placement of hematopoietic cells in the brain may increase growth-enhancing factors of axons and generate active neurons in the receptor. It has been found that after introducing hematopoietic cells in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be deliver more efficiently to the injured area, when compared to the intravenous route. Patients will be stimulated 4 times and then harvest the bone marrow. Bone marrow will be processed in order to obtain hematopoietic cells (CD34+) and minimize the erythrocytes amount. A inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with the "Battelle Developmental Inventory" before the procedure and one and six months after that. An MRI will be performed before the procedure and six months after that.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia-Ischemia, Cerebral, Cerebral Palsy
Keywords
Hypoxia, Ischemia, Brain, Children, Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Children whom will receive intrathecal autologous stem cells
Intervention Type
Procedure
Intervention Name(s)
Intrathecal Autologous Stem Cells
Other Intervention Name(s)
Autologous Stem Cells Transplantation
Intervention Description
Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 5 times, harvest bone marrow and infused 8 to 10 mL of stem cells (CD34+) by intrathecal via.
Primary Outcome Measure Information:
Title
Score of "Battelle Developmental Inventory"
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Score of "Battelle Developmental Inventory"
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with hypoxic/ischemic brain injury, with an between 1 month and 18 years, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours. Exclusion Criteria: Patients with neurodegenerative or autoimmune diseases. Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure. Patients who do not sign the informed consent form. Elimination Criteria Patients with severe meningeal abnormalities at the time of procedure. Patients who did not attend subsequent assessments 30 and 180 days after the procedure. Patients who die from causes related to neurological disease within 180 days after procedure. Patients who are diagnosed with neurodegenerative or autoimmune diseases after the procedure. Patients who do not bear the proper stimulation process with Granulocyte Colony Stimulating Factor (G-CSF), either by misapplication, lack thereof, or severe adverse drug reaction. Patients choosing to leave the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C Mancias-Guerra, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arturo Garza-Alatorre, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laura N Rodriguez-Romo, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
16624956
Citation
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Results Reference
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PubMed Identifier
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Citation
Glascoe FP, Byrne KE. The usefulness of the Battelle Developmental Inventory Screening Test. Clin Pediatr (Phila). 1993 May;32(5):273-80. doi: 10.1177/000992289303200504.
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Intrathecal Stem Cells in Brain Injury

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