Intrathecal Stem Cells in Brain Injury (ISC)

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01019733
First received: November 24, 2009
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Hypoxia-Ischemia, Cerebral
Cerebral Palsy
Procedure: Intrathecal Autologous Stem Cells

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Score of "Battelle Developmental Inventory" [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Score of "Battelle Developmental Inventory" [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Children whom will receive intrathecal autologous stem cells
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019733

Locations
Mexico
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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
  More Information

Additional Information:
Publications:

Additional 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
Study First Received: November 24, 2009
Last Updated: January 25, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Hypoxia
Ischemia
Brain
Children
Cerebral Palsy

Additional relevant MeSH terms:
Cerebral Palsy
Ischemia
Hypoxia-Ischemia, Brain
Anoxia
Brain Injuries
Brain Ischemia
Wounds and Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Cerebrovascular Disorders
Hypoxia, Brain
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 18, 2014