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...
Date First Received: November 24, 2009
Last Updated: February 8, 2010
Verified by: Hospital Universitario Dr. Jose E. Gonzalez, January 2010
Clinical Trial Phase: N/A | Start Date: July 2009
Overall Status: Active, not recruiting
Estimated Enrollment: 10
Brief Summary
Official Title: “Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Study Primary Completion Date: April 2010
Detailed Clinical Trial 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 5 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 8 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with the "Battelle Developmental Inventory" before the procedure and one and three months after that.
Intervention(s) in this Clinical Trial
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Patients
- Children whom will receive intrathecal autologous stem cells
Outcome Measures for this Clinical Trial
Primary Measures
- Score of "Battelle Developmental Inventory"
- Time Frame: 30 days
Safety Issue?: Yes
- Time Frame: 30 days
Secondary Measures
- Score of "Battelle Developmental Inventory"
- Time Frame: 180 days
Safety Issue?: Yes
- Time Frame: 180 days
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 8 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Overall Clinical Trial Officials and Contacts
Maria C Mancias-Guerra, MD Principal Investigator Hospital Universitario Dr. Jose E. Gonzalez
Related Publications
References
Felling RJ, Snyder MJ, Romanko MJ, Rothstein RP, Ziegler AN, Yang Z, Givogri MI, Bongarzone ER, Levison SW. Neural stem/progenitor cells participate in the regenerative response to perinatal hypoxia/ischemia. J Neurosci. 2006 Apr 19;26(16):4359-69.
Glascoe FP, Byrne KE. The usefulness of the Battelle Developmental Inventory Screening Test. Clin Pediatr (Phila). 1993 May;32(5):273-80.
Berls AT, McEwen IR. Battelle developmental inventory. Phys Ther. 1999 Aug;79(8):776-83. No abstract available.
Levison SW, Rothstein RP, Romanko MJ, Snyder MJ, Meyers RL, Vannucci SJ. Hypoxia/ischemia depletes the rat perinatal subventricular zone of oligodendrocyte progenitors and neural stem cells. Dev Neurosci. 2001;23(3):234-47.
Hayashi T, Iwai M, Ikeda T, Jin G, Deguchi K, Nagotani S, Zhang H, Sehara Y, Nagano I, Shoji M, Ikenoue T, Abe K. Neural precursor cells division and migration in neonatal rat brain after ischemic/hypoxic injury. Brain Res. 2005 Mar 15;1038(1):41-9.
Mehta T, Feroz A, Thakkar U, Vanikar A, Shah V, Trivedi H. Subarachnoid placement of stem cells in neurological disorders. Transplant Proc. 2008 May;40(4):1145-7.
Goldman SA, Schanz S, Windrem MS. Stem cell-based strategies for treating pediatric disorders of myelin. Hum Mol Genet. 2008 Apr 15;17(R1):R76-83. Review.
Eglitis MA, Mezey E. Hematopoietic cells differentiate into both microglia and macroglia in the brains of adult mice. Proc Natl Acad Sci U S A. 1997 Apr 15;94(8):4080-5.
Mezey E, Key S, Vogelsang G, Szalayova I, Lange GD, Crain B. Transplanted bone marrow generates new neurons in human brains. Proc Natl Acad Sci U S A. 2003 Feb 4;100(3):1364-9. Epub 2003 Jan 21.
Li Y, Chen J, Chen XG, Wang L, Gautam SC, Xu YX, Katakowski M, Zhang LJ, Lu M, Janakiraman N, Chopp M. Human marrow stromal cell therapy for stroke in rat: neurotrophins and functional recovery. Neurology. 2002 Aug 27;59(4):514-23.
Gordon PH, Yu Q, Qualls C, Winfield H, Dillon S, Greene PE, Fahn S, Breeze RE, Freed CR, Pullman SL. Reaction time and movement time after embryonic cell implantation in Parkinson disease. Arch Neurol. 2004 Jun;61(6):858-61.
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019733
Study ID Number: HE09-014
ClinicalTrials.gov Identifier: NCT01019733
Health Authority: Mexico: Ethics Committee
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
