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NCT02551003

Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy

Withdrawn Phase 1, PHASE2 Last updated 29 December 2023
What this trial tests

Phase 1, PHASE2 trial testing Autologous cord blood in Hypoxic Ischemic Encephalopathy. Withdrawn.

Timeline
8 September 2015
Primary endpoint
30 December 2016
30 December 2016

Quick facts

Lead sponsorChildren's Hospital of Fudan University
PhasePhase 1, PHASE2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Start date8 September 2015
Primary completion30 December 2016
Estimated completion30 December 2016
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital of Fudan University

Who can join

Under 24 Hours, any sex, with Hypoxic Ischemic Encephalopathy or Cerebral Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

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. Neonatal asphyxia as an inflammatory disease: Reactive oxygen species and cytokines.
    Okazaki K, Nakamura S, Koyano K, Konishi Y, et al · · 2023 · cited 16× · PMID 36776908 · DOI 10.3389/fped.2023.1070743
  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. Neonatal encephalopathy due to suspected hypoxic ischemic encephalopathy: pathophysiology, current, and emerging treatments.
    Babbo CC, Mellet J, van Rensburg J, Pillay S, et al · · 2024 · cited 13× · PMID 39237728 · DOI 10.1007/s12519-024-00836-9
  7. 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
  8. Rationale for the Use of Cord Blood in Hypoxic-Ischaemic Encephalopathy.
    Zdolińska-Malinowska I, Boruczkowski D, Hołowaty D, Krajewski P, et al · · 2022 · cited 5× · PMID 35599846 · DOI 10.1155/2022/9125460

Verify or expand the search:

Other recruiting trials for Hypoxic Ischemic Encephalopathy

Currently open trials in the same condition.

Other Children's Hospital of Fudan University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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