Autologous Stem Cells in Newborns With Oxygen Deprivation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| 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 | |
| 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 | |
| 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 Anoxia Hypoxia, Brain Acid-Base Imbalance Metabolic Diseases Shock |
Pathologic Processes Signs and Symptoms, Respiratory Signs and Symptoms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013