The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03696745|
Recruitment Status : Unknown
Verified October 2018 by yangjie, Guangdong Women and Children Hospital.
Recruitment status was: Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues Effect of Drugs||Other: autologous umbilical cord blood stem cells Drug: 0.9% Sodium-chloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2021|
Placebo Comparator: Placebo
preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride
Drug: 0.9% Sodium-chloride
0.9% Sodium-chloride in control group
preterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg
Other: autologous umbilical cord blood stem cells
autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation
- safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants [ Time Frame: during infusion 24 hours after infusion ]Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group
- effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants [ Time Frame: 1 year ]the effect of autologous umbilical cord blood stem cells infusion will be measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||28 Weeks to 37 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Mothers must have consented for cord blood collection at delivery
cord blood must be available for extraction of stem cells.
->28 weeks gestation,<37weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
- All infants must have signs of encephalopathy within 6 hours of age.
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
- Parents refuse consent.
- Attending neonatologist refuses consent.
- Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696745
|Contact: ZhuXiao Ren, MD||+8613538984634 ext +email@example.com|
|Contact: Jie Yang, PHD||39151777 ext 020||Jjieyang0830@163.com|
|Principal Investigator:||Jie Yang, PHD||Gunagzhou,Guangdong,China,511442|
|Responsible Party:||yangjie, Professor, Guangdong Women and Children Hospital|
|Other Study ID Numbers:||
GuangdongW C H
|First Posted:||October 5, 2018 Key Record Dates|
|Last Update Posted:||October 5, 2018|
|Last Verified:||October 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Autologous Umbilical Cord Blood Stem Cells
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries