NCT03352310

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Status unknown Phase 1 Last updated 7 June 2018

What this trial tests

Phase 1 trial testing autologous umbilical cord blood (UCB) in Hypoxic-Ischemic Encephalopathy in 40 participants. Status unknown.

Timeline

16 April 2018

Primary endpoint
30 June 2020

30 December 2020

Quick facts

Lead sponsor	Mononuclear Therapeutics Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	16 April 2018
Primary completion	30 June 2020
Estimated completion	30 December 2020
Sites	1 location across Hong Kong

Drugs / interventions tested

• autologous umbilical cord blood (UCB) — full drug profile →
• standard care — full drug profile →

Conditions studied

• Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →
• Hypoxia Neonatal — all drugs for Hypoxia Neonatal →
• Cerebral Ischemia of Newborn — all drugs for Cerebral Ischemia of Newborn →
• Anemia, Neonatal — all drugs for Anemia, Neonatal →

Sponsor

Mononuclear Therapeutics Ltd. — full company profile →

Who can join

Under 48 Hours, any sex, with Hypoxic-Ischemic Encephalopathy or Hypoxia Neonatal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group.

Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
   Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653
2. Emergent Prophylactic, Reparative and Restorative Brain Interventions for Infants Born Preterm With Cerebral Palsy.
   Finch-Edmondson M, Morgan C, Hunt RW, Novak I. · · 2019 · cited 29× · PMID 30745876 · DOI 10.3389/fphys.2019.00015
3. Stem cell-based interventions for the prevention of morbidity and mortality following hypoxic-ischaemic encephalopathy in newborn infants.
   Bruschettini M, Romantsik O, Moreira A, Ley D, et al · · 2020 · cited 23× · PMID 32813884 · DOI 10.1002/14651858.cd013202.pub2
4. Cell-based treatment for perinatal hypoxic-ischemic encephalopathy.
   Park YJ, Borlongan CV, Dezawa M. · · 2021 · cited 16× · PMID 34084971 · DOI 10.4103/bc.bc_7_21
5. Autologous cord blood in children with cerebral palsy: a review.
   Boruczkowski D, Pujal JM, Zdolińska-Malinowska I. · · 2019 · cited 14× · PMID 31100943 · DOI 10.3390/ijms20102433
6. Hypothermia combined with neuroprotective adjuvants shortens the duration of hospitalization in infants with hypoxic ischemic encephalopathy: Meta-analysis.
   Ovcjak A, Pontello R, Miller SP, Sun HS, et al · · 2022 · cited 13× · PMID 36686686 · DOI 10.3389/fphar.2022.1037131
7. Stem cell-based interventions for the treatment of stroke in newborn infants.
   Bruschettini M, Badura A, Romantsik O. · · 2023 · cited 5× · PMID 37994736 · DOI 10.1002/14651858.cd015582.pub2
8. Application of Umbilical Cord Blood for the Clinical Prevention and Treatment of Complications in Preterm Infants(Review).
   Xu L, Shuzhe X, Jie Y. · · 2026 · PMID 41021185 · DOI 10.1007/s12015-025-10988-4