Intrathecal Stem Cells in Brain Injury (ISC)
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ClinicalTrials.gov Identifier: NCT01019733 |
Recruitment Status
:
Completed
First Posted
: November 25, 2009
Last Update Posted
: January 26, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoxia-Ischemia, Cerebral Cerebral Palsy | Procedure: Intrathecal Autologous Stem Cells | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | January 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Patients
Children whom will receive intrathecal autologous stem cells
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Procedure: Intrathecal Autologous Stem Cells
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.
Other Name: Autologous Stem Cells Transplantation
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- Score of "Battelle Developmental Inventory" [ Time Frame: 30 days ]
- Score of "Battelle Developmental Inventory" [ Time Frame: 180 days ]

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Ages Eligible for Study: | 1 Year to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019733
Mexico | |
Hospital Universitario Dr. Jose E. Gonzalez | |
Monterrey, Nuevo Leon, Mexico, 64460 |
Principal Investigator: | Maria C Mancias-Guerra, MD | Hospital Universitario Dr. Jose E. Gonzalez | |
Study Director: | Arturo Garza-Alatorre, MD | Hospital Universitario Dr. Jose E. Gonzalez | |
Study Chair: | Laura N Rodriguez-Romo, MD | Hospital Universitario Dr. Jose E. Gonzalez |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Maria del Consuelo Mancías Guerra, Hospital Universitario Dr. José E. González |
ClinicalTrials.gov Identifier: | NCT01019733 History of Changes |
Other Study ID Numbers: |
HE09-014 |
First Posted: | November 25, 2009 Key Record Dates |
Last Update Posted: | January 26, 2011 |
Last Verified: | January 2011 |
Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Hypoxia Ischemia Brain Children Cerebral Palsy |
Additional relevant MeSH terms:
Brain Injuries Ischemia Cerebral Palsy Hypoxia Brain Ischemia Hypoxia-Ischemia, Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma |
Trauma, Nervous System Wounds and Injuries Pathologic Processes Brain Damage, Chronic Signs and Symptoms, Respiratory Signs and Symptoms Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Hypoxia, Brain |