Autologous Stem Cells in Newborns With Oxygen Deprivation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01506258
First received: January 5, 2012
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.


Condition Intervention
Apgar; 0-3 at 1 Minute
Metabolic Acidosis
Hypoxia, Brain
Multiple Organ Failure
Procedure: Application of Stem Cells
Procedure: Observation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Effects of Stem Cell Infusion at 1 week after discharge [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Clinical assessment, including the Amiel-Tison Neurological Assessment

  • Effects of Stem Cell Infusion at 1 year after discharge [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Clinical assessment, including the Amiel-Tison Neurological Assessment


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Patients not infused with stem cells
Historic Controls
Procedure: Observation
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Other Name: Comparison group
Experimental: Patients infused with stem cells Procedure: Application of Stem Cells
IV infusion of autologous stem cells within the first 48 hours after birth.
Other Name: IV infusion of autologous cord and placental cord blood

Detailed Description:

When there is oxygen deprivation, more frequently in premature newborns, the brain and other organs suffer severe consequences. There is evidence that hematopoietic stem cells can help in this scenario by promoting the release of growth-enhancing factors that can help control the damage due to their "homing" capacity, which attracts them to injured sites.

Cord and placental blood have a high concentration of these stem cells, and because its obtention is relatively easy, it seems like a feasible treatment in perinatal hypoxia.

There are current clinical trials that use cryopreserved cord blood for these patients but, to do that, the stem cells have to be frozen and then thawed to be infused, losing a considerable amount of stem cells (almost half of them). We want to evaluate the same condition but infusing non-cryopreserved autologous cord and placental blood because we believe it can be more beneficial due to the greater amount of cells infused, the avoidance of the cryoprotection agent´s toxicity and the lower costs.

  Eligibility

Ages Eligible for Study:   37 Weeks to 42 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Apgar < 5 at 5 minutes
  • Mixed or metabolic acidosis with a pH <7.0 from umbilical cord blood sample
  • Neurological manifestations compatible with Hypoxic-Ischemic Encephalopathy
  • Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory)

Exclusion Criteria:

  • Neurodegenerative, autoimmune or genetic disease
  • Active infection at birth
  • Informed Consent not signed
  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: NCT01506258

Contacts
Contact: Consuelo Mancias-Guerra, MD +52 81 83 48 61 36 ext 413 consuelo@mancias.com
Contact: Alma R Marroquin-Escamilla, MD +52 81 83 48 61 36 arme25@yahoo.com

Locations
Mexico
Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Consuelo Mancias-Guerra, MD    +52 01 86 75 67 18    consuelo@mancias.com   
Sub-Investigator: Alma R Marroquin-Escamilla, MD         
Sub-Investigator: Ana Cecilia Sosa-Cortez, MD         
Sub-Investigator: Sagrario L Valdes-Burnes, MD         
Sub-Investigator: Barbara G Cardenas-del Castillo, MD         
Sub-Investigator: Adriana Nieto-Sanjuanero, MD         
Sub-Investigator: Oscar Gonzalez-Llano, MD         
Sub-Investigator: Laura Villarreal-Martinez, MD         
Sub-Investigator: Laura M Nuño-Vazquez, MD         
Sub-Investigator: Josue E Rios-Solis, MD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Consuelo Mancias-Guerra, MD Hospital Universitario Dr. Jose E. Gonzalez
Study Director: Alma R Marroquin-Escamilla, MD Hospital Universitario Dr. Jose E. Gonzalez
Study Chair: David Gómez-Almaguer, MD Hospital Universitario Dr. Jose E. Gonzalez
  More Information

Additional Information:
No publications provided

Responsible Party: Consuelo Mancias Guerra, Pediatric Hematology Professor, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01506258     History of Changes
Other Study ID Numbers: HE-11-011
Study First Received: January 5, 2012
Last Updated: January 18, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
CD34+
perinatal hypoxia
autologous hematopoietic stem cells
cord and placental blood
cerebral palsy

Additional relevant MeSH terms:
Acidosis
Multiple Organ Failure
Hypoxia, Brain
Acid-Base Imbalance
Metabolic Diseases
Shock
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 29, 2014