Intrathecal Stem Cells in Brain Injury

Cerebral Palsy Clinical Trial

— ISC  

Official title:

Intrathecal Autologous Stem Cells for Children With Hipoxic/Ischemic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019733
• Other study ID #: HE09-014
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: January 25, 2011
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Ischemia
• Cerebral Palsy
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxia-Ischemia, Cerebral
• Ischemia

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. Jose E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

Berls AT, McEwen IR. Battelle developmental inventory. Phys Ther. 1999 Aug;79(8):776-83. — View Citation

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. — View Citation

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. — View Citation

Glascoe FP, Byrne KE. The usefulness of the Battelle Developmental Inventory Screening Test. Clin Pediatr (Phila). 1993 May;32(5):273-80. — View Citation

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. doi: 10.1093/hmg/ddn052. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.transproceed.2008.03.026. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of "Battelle Developmental Inventory"		30 days
Secondary	Score of "Battelle Developmental Inventory"		180 days