Autologous Umbilical Cord Blood Mononuclear Layer Transfusion for Neonates with Encephalopathy: A Pilot Feasibility Study

Efficacy of Autologous Umbilical Cord Blood Mononuclear Layer Transfusion to Prevent Brain injury after Neonatal encephalopathy.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000421033

Enrollment

Registered

2010-05-26

Start date

2010-06-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Hours to 24 Hours

Healthy volunteers

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.

Exclusion criteria

*Presence of known chromosomal anomaly. *Presence of major congenital anomalies.

Outcome results