Apgar; 0-3 at 1 MinuteNCT01506258
Autologous Stem Cells in Newborns With Oxygen Deprivation
A study testing Application of Stem Cells and Observation in people with Apgar; 0-3 at 1 Minute and Metabolic Acidosis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Apgar; 0-3 at 1 Minute, Metabolic Acidosis, Hypoxia, Brain
- What is being tested?
- Application of Stem Cells and Observation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Neurodegenerative, autoimmune or genetic disease
- Active infection at birth
- Informed Consent not signed
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Neonatology Department of the Pediatrics Service, Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
Consuelo Mancias-Guerra, MD, +52 01 86 75 67 18, consuelo@mancias.com
Alma R Marroquin-Escamilla, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Application of Stem Cells, Observation
- Keywords
- CD34+, perinatal hypoxia, autologous hematopoietic stem cells, cord and placental blood, cerebral palsy
- Medical subject headings
- Acidosis, Hypoxia, Brain, Multiple Organ Failure, Cone-Rod Dystrophies, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Stem CellsProcedure or surgery
Also called IV infusion of autologous cord and placental cord blood
IV infusion of autologous stem cells within the first 48 hours after birth.
ObservationProcedure or surgery
Also called Comparison group
Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients not infused with stem cells | No intervention | Historic Controls Receives: Procedure: Observation |
| Patients infused with stem cells | Experimental | Not described Receives: Procedure: Application of Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Stem Cell Infusion at 1 week after discharge
Clinical assessment, including the Amiel-Tison Neurological Assessment
Measured: 1 week
Effects of Stem Cell Infusion at 1 year after discharge
Clinical assessment, including the Amiel-Tison Neurological Assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apgar; 0-3 at 1 MinuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Consuelo Mancias-Guerra, MD, Principal investigator, Hospital Universitario Dr. Jose E. GonzalezAlma R Marroquin-Escamilla, MD, Study director, Hospital Universitario Dr. Jose E. GonzalezDavid Gómez-Almaguer, MD, Study chair, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506258
- Sponsor's protocol ID
- HE-11-011
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia
- ClinicalTrials.gov ID
- NCT01506258
- Acronym / sponsor ID
- HE-11-011
- Keywords
- CD34+, perinatal hypoxia, autologous hematopoietic stem cells, cord and placental blood, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients not infused with stem cells | No intervention | Procedure: ObservationHistoric Controls |
| Patients infused with stem cells | Experimental | Procedure: Application of Stem Cells |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Neurodegenerative, autoimmune or genetic disease
- Active infection at birth
- Informed Consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Stem CellsAlso: IV infusion of autologous cord and placental cord bloodIV infusion of autologous stem cells within the first 48 hours after birth. | Procedure or surgery | Patients infused with stem cells |
| ObservationAlso: Comparison groupControl group of patients that meet the inclusion criteria but that do not wish to have the intervention. | Procedure or surgery | Patients not infused with stem cells |
Primary outcome
Effects of Stem Cell Infusion at 1 week after discharge
Time frame: 1 week
Clinical assessment, including the Amiel-Tison Neurological Assessment
Effects of Stem Cell Infusion at 1 year after discharge
Time frame: 1 year
Clinical assessment, including the Amiel-Tison Neurological Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Consuelo Mancias-Guerra, MD principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
Alma R Marroquin-Escamilla, MD study director
Hospital Universitario Dr. Jose E. Gonzalez
David Gómez-Almaguer, MD study chair
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Stem Cells and Observation in people with Apgar; 0-3 at 1 Minute and Metabolic Acidosis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Consuelo Mancias-Guerra, MD (+52 81 83 48 61 36 ext. 413, consuelo@mancias.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Stem Cell Infusion at 1 week after discharge (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.