Autologous Stem Cells in Newborns With Oxygen Deprivation

Multiple Organ Failure Clinical Trial

Official title:

Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01506258
• Other study ID #: HE-11-011
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2012
• Last updated: January 18, 2012
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2012
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Consuelo Mancias-Guerra, MD
• Phone: +52 81 83 48 61 36
• Email: consuelo[@]mancias.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 37 Weeks to 42 Weeks

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acidosis
• Apgar; 0-3 at 1 Minute
• Hypoxia, Brain
• Metabolic Acidosis
• Multiple Organ Failure

Intervention

Procedure:
• Application of Stem Cells
IV infusion of autologous stem cells within the first 48 hours after birth.
• Observation
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.

Locations

Country	Name	City	State
Mexico	Neonatology Department of the Pediatrics Service, 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Stem Cell Infusion at 1 week after discharge	Clinical assessment, including the Amiel-Tison Neurological Assessment	1 week	Yes
Primary	Effects of Stem Cell Infusion at 1 year after discharge	Clinical assessment, including the Amiel-Tison Neurological Assessment	1 year	Yes

External Links

•   Hematology Service web page