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NCT02551003
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
Phase 1, PHASE2 trial testing Autologous cord blood in Hypoxic Ischemic Encephalopathy. Withdrawn.
30 December 2016
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 8 September 2015 |
| Primary completion | 30 December 2016 |
| Estimated completion | 30 December 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Autologous cord blood — full drug profile →
- Hypothermia
Conditions studied
- Hypoxic Ischemic Encephalopathy — all drugs for Hypoxic Ischemic Encephalopathy →
- Cerebral Infarction — all drugs for Cerebral Infarction →
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):
-
Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02551003
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
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- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02551003 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Fudan University
- Last refreshed: 29 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02551003.
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