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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

November 24, 2009
January 25, 2011
July 2009
April 2010   (final data collection date for primary outcome measure)
Score of "Battelle Developmental Inventory" [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01019733 on ClinicalTrials.gov Archive Site
Score of "Battelle Developmental Inventory" [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intrathecal Stem Cells in Brain Injury
Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypoxia-Ischemia, Cerebral
  • Cerebral Palsy
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
Experimental: Patients
Children whom will receive intrathecal autologous stem cells
Intervention: Procedure: Intrathecal Autologous Stem Cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2011
April 2010   (final data collection date for primary outcome measure)

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.
Both
1 Year to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01019733
HE09-014
Yes
Maria del Consuelo Mancías Guerra, Hospital Universitario Dr. José E. González
Hospital Universitario Dr. Jose E. Gonzalez
Not Provided
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
Hospital Universitario Dr. Jose E. Gonzalez
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP