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Autologous Stem Cells in Newborns With Oxygen Deprivation

Primary Purpose

Apgar; 0-3 at 1 Minute, Metabolic Acidosis, Hypoxia, Brain

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Application of Stem Cells
Observation
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apgar; 0-3 at 1 Minute focused on measuring CD34+, perinatal hypoxia, autologous hematopoietic stem cells, cord and placental blood, cerebral palsy

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. GonzalezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Patients not infused with stem cells

Patients infused with stem cells

Arm Description

Historic Controls

Outcomes

Primary Outcome Measures

Effects of Stem Cell Infusion at 1 week after discharge
Clinical assessment, including the Amiel-Tison Neurological Assessment
Effects of Stem Cell Infusion at 1 year after discharge
Clinical assessment, including the Amiel-Tison Neurological Assessment

Secondary Outcome Measures

Full Information

First Posted
January 5, 2012
Last Updated
January 18, 2012
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT01506258
Brief Title
Autologous Stem Cells in Newborns With Oxygen Deprivation
Official Title
Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apgar; 0-3 at 1 Minute, Metabolic Acidosis, Hypoxia, Brain, Multiple Organ Failure
Keywords
CD34+, perinatal hypoxia, autologous hematopoietic stem cells, cord and placental blood, cerebral palsy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients not infused with stem cells
Arm Type
No Intervention
Arm Description
Historic Controls
Arm Title
Patients infused with stem cells
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Application of Stem Cells
Other Intervention Name(s)
IV infusion of autologous cord and placental cord blood
Intervention Description
IV infusion of autologous stem cells within the first 48 hours after birth.
Intervention Type
Procedure
Intervention Name(s)
Observation
Other Intervention Name(s)
Comparison group
Intervention Description
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
Primary Outcome Measure Information:
Title
Effects of Stem Cell Infusion at 1 week after discharge
Description
Clinical assessment, including the Amiel-Tison Neurological Assessment
Time Frame
1 week
Title
Effects of Stem Cell Infusion at 1 year after discharge
Description
Clinical assessment, including the Amiel-Tison Neurological Assessment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Consuelo Mancias-Guerra, MD
Phone
+52 81 83 48 61 36
Ext
413
Email
consuelo@mancias.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alma R Marroquin-Escamilla, MD
Phone
+52 81 83 48 61 36
Email
arme25@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Consuelo Mancias-Guerra, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alma R Marroquin-Escamilla, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Gómez-Almaguer, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Chair
Facility Information:
Facility Name
Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Consuelo Mancias-Guerra, MD
Phone
+52 01 86 75 67 18
Email
consuelo@mancias.com
First Name & Middle Initial & Last Name & Degree
Alma R Marroquin-Escamilla, MD
First Name & Middle Initial & Last Name & Degree
Ana Cecilia Sosa-Cortez, MD
First Name & Middle Initial & Last Name & Degree
Sagrario L Valdes-Burnes, MD
First Name & Middle Initial & Last Name & Degree
Barbara G Cardenas-del Castillo, MD
First Name & Middle Initial & Last Name & Degree
Adriana Nieto-Sanjuanero, MD
First Name & Middle Initial & Last Name & Degree
Oscar Gonzalez-Llano, MD
First Name & Middle Initial & Last Name & Degree
Laura Villarreal-Martinez, MD
First Name & Middle Initial & Last Name & Degree
Laura M Nuño-Vazquez, MD
First Name & Middle Initial & Last Name & Degree
Josue E Rios-Solis, MD

12. IPD Sharing Statement

Learn more about this trial

Autologous Stem Cells in Newborns With Oxygen Deprivation

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