Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 5, 2012
January 18, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01506258 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Autologous Stem Cells in Newborns With Oxygen Deprivation
Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Apgar; 0-3 at 1 Minute
  • Metabolic Acidosis
  • Hypoxia, Brain
  • Multiple Organ Failure
  • 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
  • Procedure: Observation
    Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
    Other Name: Comparison group
  • No Intervention: Patients not infused with stem cells
    Historic Controls
    Intervention: Procedure: Observation
  • Experimental: Patients infused with stem cells
    Intervention: Procedure: Application of Stem Cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
37 Weeks to 42 Weeks
No
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
Mexico
 
NCT01506258
HE-11-011
Yes
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
Hospital Universitario Dr. Jose E. Gonzalez
Not Provided
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
Hospital Universitario Dr. Jose E. Gonzalez
January 2012

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