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Trial registered on ANZCTR


Trial ID
ACTRN12610000421033
Ethics application status
Approved
Date submitted
13/05/2010
Date registered
26/05/2010
Date last updated
29/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Autologous Umbilical Cord Blood Mononuclear Layer Transfusion for Neonates with Encephalopathy: A Pilot Feasibility Study
Scientific title
Efficacy of Autologous Umbilical Cord Blood Mononuclear Layer Transfusion to Prevent Brain injury after Neonatal encephalopathy.
Secondary ID [1] 251801 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Encephalopathy. 257362 0
Asphyxia and traumatic brain injury. 257363 0
Condition category
Condition code
Neurological 257508 257508 0 0
Other neurological disorders
Reproductive Health and Childbirth 257544 257544 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous cord blood collection after birth of the baby (10 min), immediately followed by Mononuclear cell layer (MNCL) separation by density gradient centrifugation (30 min), immediately followed by MNCL transfusion over 30 minutes to preterm or full term neonate with signs of encephalopathy.
Intervention code [1] 256470 0
Prevention
Intervention code [2] 256504 0
Treatment: Other
Comparator / control treatment
Historical data will be collected from files for neonates with encephalopathy admitted to the Neonatal Intensive Care Unit (NICU) during the period from 2005 till 2010. They were treated with supportive care.
Control group
Historical

Outcomes
Primary outcome [1] 258426 0
Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. Occurance of blood pressure fluctuation, changes in heart rate, reaction to blood transfusion. The baby will be monitored for mean arterial blood pressure and heart rate and blood analysis .
Timepoint [1] 258426 0
1 month following transfusion.
Secondary outcome [1] 264205 0
Prevention of brain injury as measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age.Bayley II Scales of Infant Development will be used.
Timepoint [1] 264205 0
4-6 months and 9-12 months of age.
Secondary outcome [2] 264206 0
Magnetic resonance imaging (MRI) findings compared to historical non interventional group. MRI score will be used.
Timepoint [2] 264206 0
1 year of age.

Eligibility
Key inclusion criteria
*Mothers must have consented for cord blood collection at delivery
*cord blood must be available for extraction of stem cells.
*>30 weeks gestation
*High risk pregnancies.
*All infants must have signs of encephalopathy within 6 hours of age.
Minimum age
1 Hours
Maximum age
24 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Presence of known chromosomal anomaly.
*Presence of major congenital anomalies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment outside Australia
Country [1] 2626 0
Egypt
State/province [1] 2626 0
Cairo

Funding & Sponsors
Funding source category [1] 256966 0
Self funded/Unfunded
Name [1] 256966 0
Address [1] 256966 0
Country [1] 256966 0
Egypt
Primary sponsor type
University
Name
Ain Shams University, Faculty of Medicine
Address
Abassia square/Cairo. 11588
Country
Egypt
Secondary sponsor category [1] 256228 0
Hospital
Name [1] 256228 0
Pediatric department , Children's Hospital
Address [1] 256228 0
Faculty of Medicine/Ain Shams University/Abassia square/Cairo. 11588
Country [1] 256228 0
Egypt
Other collaborator category [1] 1254 0
Hospital
Name [1] 1254 0
Maternity Hospital/ Ain Shams University
Address [1] 1254 0
Faculty of Medicine/Ain Shams University/Abassia square/Cairo. 11588
Country [1] 1254 0
Egypt
Other collaborator category [2] 1255 0
Hospital
Name [2] 1255 0
Neonatal Intensive Care Unit-Maternity Hospital/ Ain Shams University
Address [2] 1255 0
Faculty of Medicine/Ain Shams University/Abassia square/Cairo.11588
Country [2] 1255 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258983 0
Ain Shams Medical School. Surgery Department
Ethics committee address [1] 258983 0
Faculty of Medicine/Ain Shams University/Abassia square/Cairo.11588
Ethics committee country [1] 258983 0
Egypt
Date submitted for ethics approval [1] 258983 0
02/02/2010
Approval date [1] 258983 0
01/03/2010
Ethics approval number [1] 258983 0
IRB 00006379

Summary
Brief summary
The primary objective of this study is to determine feasibility and safety of the procedure of cord blood collection, preservation and autologus transfusion. The protective effect of mononuclear layer transfusion for neonates with encephalopathy, to decrease long term sequel.
Trial website
Trial related presentations / publications
1. Robertson, C.M., N.N. Finer, and M.G. Grace, School performance of survivors of neonatal encephalopathy associated with birth asphyxia at term. J Pediatr, 1989. 114(5): p. 753-60.
2. CDC, Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment--United States, 2003. MMWR Morb Mortal Wkly Rep, 2004. 53(3): p. 57-9.
3. Campbell, O., et al., The Egypt National Perinatal/Neonatal Mortality Study 2000. J Perinatol, 2004. 24(5): p. 284-9.
4. Sanberg, P.R., et al., Umbilical cord blood-derived stem cells and brain repair. Ann N Y Acad Sci, 2005. 1049: p. 67-83.
5. Buschmann, I.R., et al., GM-CSF: a strong arteriogenic factor acting by amplification of monocyte function. Atherosclerosis, 2001. 159(2): p. 343-56.
6. Taguchi, A., et al., Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest, 2004. 114(3): p. 330-8.
7. Peterson, D.A., Umbilical cord blood cells and brain stroke injury: bringing in fresh blood to address an old problem. J Clin Invest, 2004. 114(3): p. 312-4.
8. Sanchez-Ramos, J.R., et al., Expression of neural markers in human umbilical cord blood. Exp Neurol, 2001. 171(1): p. 109-15.
9. Bicknese, A.R., et al., Human umbilical cord blood cells can be induced to express markers for neurons and glia. Cell Transplant, 2002. 11(3): p. 261-4.
10. Fraidenraich, D., et al., Rescue of cardiac defects in id knockout embryos by injection of embryonic stem cells. Science, 2004. 306(5694): p. 247-52.
11. Buzanska, L., M. Jurga, and K. Domanska-Janik, Neuronal differentiation of human umbilical cord blood neural stem-like cell line. Neurodegener Dis, 2006. 3(1-2): p. 19-26.
12. Shellhaas, R.A., P.R. Gallagher, and R.R. Clancy, Assessment of neonatal electroencephalography (EEG) background by conventional and two amplitude-integrated EEG classification systems. J Pediatr, 2008. 153(3): p. 369-74.
13. Luan, Z., et al., [Treatment of an infant with severe neonatal hypoxic-ischemic encephalopathy sequelae with transplantation of human neural stem cells into cerebral ventricle]. Zhonghua Er Ke Za Zhi, 2005. 43(8): p. 580-3; discussion 580.
Public notes

Contacts
Principal investigator
Name 31160 0
Address 31160 0
Country 31160 0
Phone 31160 0
Fax 31160 0
Email 31160 0
Contact person for public queries
Name 14407 0
Prof. Dr. Sahar MA Hassanein
Address 14407 0
129 Merghani St., Heliopolies. Cairo. Egypt. 11361
Country 14407 0
Egypt
Phone 14407 0
+20123183943
Fax 14407 0
Email 14407 0
saharhassanein@yahoo.com
Contact person for scientific queries
Name 5335 0
Prof. Dr. Sahar MA Hassanein
Address 5335 0
Faculty of Medicine/Ain Shams University/Abassia square/Cairo. 11588
Country 5335 0
Egypt
Phone 5335 0
+20123183943
Fax 5335 0
Email 5335 0
saharhassanein@yahoo.com