PMID- 36790019 OWN - NLM STAT- MEDLINE DCOM- 20230216 LR - 20240216 IS - 1469-493X (Electronic) IS - 1361-6137 (Linking) VI - 2 IP - 2 DP - 2023 Feb 15 TI - Stem cell-based interventions for the prevention and treatment of intraventricular haemorrhage and encephalopathy of prematurity in preterm infants. PG - CD013201 LID - 10.1002/14651858.CD013201.pub3 [doi] LID - CD013201 AB - BACKGROUND: Germinal matrix-intraventricular haemorrhage (GMH-IVH) and encephalopathy of prematurity (EoP) remain substantial issues in neonatal intensive care units worldwide. Current therapies to prevent or treat these conditions are limited. Stem cell-based therapies offer a potential therapeutic approach to repair, restore, or regenerate injured brain tissue. These preclinical findings have now culminated in ongoing human neonatal studies. This is an update of the 2019 review, which did not include EoP. OBJECTIVES: To evaluate the benefits and harms of stem cell-based interventions for prevention or treatment of GM-IVH and EoP in preterm infants. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was April 2022. SELECTION CRITERIA: We attempted to include randomised controlled trials, quasi-randomised controlled trials, and cluster trials comparing 1. stem cell-based interventions versus control; 2. mesenchymal stromal cells (MSCs) of type or source versus MSCs of other type or source; 3. stem cell-based interventions other than MSCs of type or source versus stem cell-based interventions other than MSCs of other type or source; or 4. MSCs versus stem cell-based interventions other than MSCs. For prevention studies, we included extremely preterm infants (less than 28 weeks' gestation), 24 hours of age or less, without ultrasound diagnosis of GM-IVH or EoP; for treatment studies, we included preterm infants (less than 37 weeks' gestation), of any postnatal age, with ultrasound diagnosis of GM-IVH or with EoP. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. all-cause neonatal mortality, 2. major neurodevelopmental disability, 3. GM-IVH, 4. EoP, and 5. extension of pre-existing non-severe GM-IVH or EoP. We planned to use GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We identified no studies that met our inclusion criteria. Three studies are currently registered and ongoing. Phase 1 trials are described in the 'Excluded studies' section. AUTHORS' CONCLUSIONS: No evidence is currently available to evaluate the benefits and harms of stem cell-based interventions for treatment or prevention of GM-IVH or EoP in preterm infants. We identified three ongoing studies, with a sample size range from 20 to 200. In two studies, autologous cord blood mononuclear cells will be administered to extremely preterm infants via the intravenous route; in one, intracerebroventricular injection of MSCs will be administered to preterm infants up to 34 weeks' gestational age. CI - Copyright (c) 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. FAU - Romantsik, Olga AU - Romantsik O AD - Department of Clinical Sciences Lund, Paediatrics, Lund University, Skane University Hospital, Lund, Sweden. FAU - Moreira, Alvaro AU - Moreira A AD - Pediatrics, Division of Neonatology, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA. FAU - Thebaud, Bernard AU - Thebaud B AD - Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Canada. AD - Ottawa Hospital Research Institute, Sprott Centre for Stem Cell Research, Ottawa, Canada. AD - Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Canada. FAU - Aden, Ulrika AU - Aden U AD - Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden. FAU - Ley, David AU - Ley D AD - Department of Clinical Sciences Lund, Paediatrics, Lund University, Skane University Hospital, Lund, Sweden. FAU - Bruschettini, Matteo AU - Bruschettini M AD - Department of Clinical Sciences Lund, Paediatrics, Lund University, Skane University Hospital, Lund, Sweden. AD - Cochrane Sweden, Lund University, Skane University Hospital, Lund, Sweden. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20230215 PL - England TA - Cochrane Database Syst Rev JT - The Cochrane database of systematic reviews JID - 100909747 SB - IM UOF - Cochrane Database Syst Rev. 2019 Sep 24;9:CD013201. PMID: 31549743 MH - Infant MH - Infant, Newborn MH - Humans MH - *Cerebral Hemorrhage/prevention & control MH - Infant, Extremely Premature MH - *Infant, Premature, Diseases/prevention & control/etiology MH - Infant Mortality MH - Stem Cells PMC - PMC9932000 COIS- OR: none. AM: has received non-profit research funding from the Eunice Kennedy Shriver NICHD and the Francis Family Foundation. BT: none. UA: has received non-profit research funding from the Swedish Research Council (VR 2021-06570 and VR 2020-02441), ALF grant and the Swedish Brain Foundation; a grant from Brain Repair, an academic company for a study on umbilical cord cells. DL: none. MB has received research funding from ALF grant (non-profit - Lund University) for research projects not related to Cochrane; and is an Associate Editor with the Cochrane Neonatal review group, but was not involved in editorial assessment of this manuscript. EDAT- 2023/02/16 06:00 MHDA- 2023/02/17 06:00 PMCR- 2024/02/15 CRDT- 2023/02/15 07:03 PHST- 2023/02/15 07:03 [entrez] PHST- 2023/02/16 06:00 [pubmed] PHST- 2023/02/17 06:00 [medline] PHST- 2024/02/15 00:00 [pmc-release] AID - CD013201.pub3 [pii] AID - 10.1002/14651858.CD013201.pub3 [doi] PST - epublish SO - Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD013201. doi: 10.1002/14651858.CD013201.pub3.