NCT01019733

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

9 months

First QC Date

November 24, 2009

Last Update Submit

January 25, 2011

Conditions

Hypoxia-Ischemia, CerebralCerebral Palsy

Keywords

HypoxiaIschemiaBrainChildrenCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Score of "Battelle Developmental Inventory"

    30 days

Secondary Outcomes (1)

  • Score of "Battelle Developmental Inventory"

    180 days

Study Arms (1)

Patients

EXPERIMENTAL

Children whom will receive intrathecal autologous stem cells

Procedure: Intrathecal Autologous Stem Cells

Interventions

Intrathecal Autologous Stem CellsPROCEDURE

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.

Also known as: Autologous Stem Cells Transplantation
Patients

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (13)

  • 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. doi: 10.1523/JNEUROSCI.1898-05.2006.

    PMID: 16624956BACKGROUND

  • Glascoe FP, Byrne KE. The usefulness of the Battelle Developmental Inventory Screening Test. Clin Pediatr (Phila). 1993 May;32(5):273-80. doi: 10.1177/000992289303200504.

    PMID: 7686835BACKGROUND

  • Berls AT, McEwen IR. Battelle developmental inventory. Phys Ther. 1999 Aug;79(8):776-83. No abstract available.

    PMID: 10440664BACKGROUND

  • 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. doi: 10.1159/000046149.

    PMID: 11598326BACKGROUND

  • 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. doi: 10.1016/j.brainres.2004.12.048.

    PMID: 15748871BACKGROUND

  • 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.

    PMID: 18555135BACKGROUND

  • 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.

    PMID: 18632701BACKGROUND

  • 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. doi: 10.1073/pnas.94.8.4080.

    PMID: 9108108BACKGROUND

  • 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. doi: 10.1073/pnas.0336479100. Epub 2003 Jan 21.

    PMID: 12538864BACKGROUND

  • 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. doi: 10.1212/wnl.59.4.514.

    PMID: 12196642BACKGROUND

  • 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. doi: 10.1001/archneur.61.6.858.

    PMID: 15210522BACKGROUND

  • Mancias-Guerra C, Marroquin-Escamilla AR, Gonzalez-Llano O, Villarreal-Martinez L, Jaime-Perez JC, Garcia-Rodriguez F, Valdes-Burnes SL, Rodriguez-Romo LN, Barrera-Morales DC, Sanchez-Hernandez JJ, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Gomez-De Leon A, Elizondo-Riojas G, Salazar-Riojas R, Gomez-Almaguer D. Safety and tolerability of intrathecal delivery of autologous bone marrow nucleated cells in children with cerebral palsy: an open-label phase I trial. Cytotherapy. 2014 Jun;16(6):810-20. doi: 10.1016/j.jcyt.2014.01.008. Epub 2014 Mar 15.

    PMID: 24642016DERIVED

  • Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.

    PMID: 22163120DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainCerebral PalsyHypoxiaIschemia

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicPathologic Processes

Study Officials

  • Maria C Mancias-Guerra, MD

    Hospital Universitario Dr. Jose E. Gonzalez

    PRINCIPAL INVESTIGATOR

  • Arturo Garza-Alatorre, MD

    Hospital Universitario Dr. Jose E. Gonzalez

    STUDY DIRECTOR

  • Laura N Rodriguez-Romo, MD

    Hospital Universitario Dr. Jose E. Gonzalez

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2010

Study Completion

January 1, 2011

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

ME(1)