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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients not infused with stem cells | No Intervention | Historic Controls |
|
| Patients infused with stem cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of Stem Cells | Procedure | IV infusion of autologous stem cells within the first 48 hours after birth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Stem Cell Infusion at 1 week after discharge | Clinical assessment, including the Amiel-Tison Neurological Assessment | 1 week |
| Effects of Stem Cell Infusion at 1 year after discharge | Clinical assessment, including the Amiel-Tison Neurological Assessment | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Consuelo Mancias-Guerra, MD | Contact | +52 81 83 48 61 36 | 413 | consuelo@mancias.com |
| Alma R Marroquin-Escamilla, MD | Contact | +52 81 83 48 61 36 | arme25@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Consuelo Mancias-Guerra, MD | Hospital Universitario Dr. Jose E. Gonzalez | Principal Investigator |
| Alma R Marroquin-Escamilla, MD | Hospital Universitario Dr. Jose E. Gonzalez | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| D002534 | Hypoxia, Brain |
| D009102 | Multiple Organ Failure |
| D000071700 | Cone-Rod Dystrophies |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Observation | Procedure | Control group of patients that meet the inclusion criteria but that do not wish to have the intervention. |
|
|
| David Gómez-Almaguer, MD | Hospital Universitario Dr. Jose E. Gonzalez | Study Chair |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001925 | Brain Damage, Chronic |