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Trial registered on ANZCTR

Registration number

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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal Encephalopathy.

Asphyxia and traumatic brain injury.

Condition category

Condition code

Neurological

Other neurological disorders

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

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]

1 month following transfusion.

Secondary outcome [1]

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]

4-6 months and 9-12 months of age.

Secondary outcome [2]

Magnetic resonance imaging (MRI) findings compared to historical non interventional group. MRI score will be used.

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/06/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Cairo

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Egypt

Primary sponsor type

University

Name

Ain Shams University, Faculty of Medicine

Address

Abassia square/Cairo. 11588

Country

Egypt

Secondary sponsor category [1]

Hospital

Name [1]

Pediatric department , Children's Hospital

Address [1]

Faculty of Medicine/Ain Shams University/Abassia square/Cairo. 11588

Country [1]

Egypt

Other collaborator category [1]

Hospital

Name [1]

Maternity Hospital/ Ain Shams University

Address [1]

Faculty of Medicine/Ain Shams University/Abassia square/Cairo. 11588

Country [1]

Egypt

Other collaborator category [2]

Hospital

Name [2]

Neonatal Intensive Care Unit-Maternity Hospital/ Ain Shams University

Address [2]

Faculty of Medicine/Ain Shams University/Abassia square/Cairo.11588

Country [2]

Egypt

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ain Shams Medical School. Surgery Department

Ethics committee address [1]

Faculty of Medicine/Ain Shams University/Abassia square/Cairo.11588

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

02/02/2010

Approval date [1]

01/03/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof. Dr. Sahar MA Hassanein

Address

129 Merghani St., Heliopolies. Cairo. Egypt. 11361

Country

Egypt

Phone

+20123183943

Fax

[email protected]

Contact person for scientific queries

Name

Prof. Dr. Sahar MA Hassanein

Address

Faculty of Medicine/Ain Shams University/Abassia square/Cairo. 11588

Country

Egypt

Phone

+20123183943

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Stem cell-based interventions for the prevention of morbidity and mortality following hypoxic-ischaemic encephalopathy in newborn infants.	2020	https://dx.doi.org/10.1002/14651858.CD013202.pub2
Embase	Placental tissue stem cells and their role in neonatal diseases.	2022	https://dx.doi.org/10.1016/j.siny.2021.101322

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically