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Published on: August 25, 2022
Stem cell-based interventions for the prevention and treatment of germinal matrix-intraventricular haemorrhage in
Olga Romantsik1, Matteo Bruschettini, Alvaro Moreira
1Department of Clinical Sciences Lund, Paediatrics, Lund University, Skåne University Hospital, Lund, Sweden.
Insights
Stem cell therapies show promise for preventing or treating germinal matrix-intraventricular haemorrhage (GM-IVH) in preterm infants, but no completed studies currently exist to confirm their benefits or harms.
Area of Science:
- Neonatal intensive care
- Regenerative medicine
- Neuroprotection
Background:
- Germinal matrix-intraventricular haemorrhage (GMH-IVH) is a significant concern in neonatal intensive care units.
- Existing therapies for GMH-IVH are limited, creating a need for novel treatments.
- Stem cell-based therapies offer potential for repairing and regenerating injured brain tissue in neonates.
Purpose of the Study:
- To evaluate the benefits and harms of stem cell interventions for preventing or treating GM-IVH in preterm infants.
- To synthesize evidence from randomized controlled trials and quasi-randomized trials on stem cell efficacy.
Main Methods:
- Comprehensive literature search of multiple databases (CENTRAL, PubMed, Embase, CINAHL) up to January 2019.
- Inclusion criteria focused on randomized, quasi-randomized, and cluster trials involving preterm infants.
- Data extraction planned for participant characteristics, intervention details, and primary outcomes including mortality and neurodevelopmental disability.
Main Results:
- A total of 769 references were identified through the search strategy.
- No completed studies met the inclusion criteria for this review.
- One randomized controlled trial is currently ongoing, and five phase 1 trials were described in excluded studies.
Conclusions:
- There is currently no available evidence to demonstrate the benefits or harms of stem cell-based interventions for GM-IVH in preterm infants.
- Further research, including ongoing and future clinical trials, is necessary to establish the safety and efficacy of these therapies.
Background:
Germinal matrix-intraventricular haemorrhage (GMH-IVH) remains a substantial issue in neonatal intensive care units worldwide. Current therapies to prevent or treat GMH-IVH are limited. Stem cell-based therapies offer a potential therapeutic approach to repair, restore, and/or regenerate injured brain tissue. These preclinical findings have now culminated in ongoing human neonatal studies.
Objectives:
To determine the benefits and harms of stem cell-based interventions for prevention or treatment of germinal matrix-intraventricular haemorrhage (GM-IVH) in preterm infants.
Search Methods:
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1), in the Cochrane Library; MEDLINE via PubMed (1966 to 7 January 2019); Embase (1980 to 7 January 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 7 January 2019). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
Selection Criteria:
We attempted to identify 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; for treatment studies, we included preterm infants (less than 37 weeks' gestation), of any postnatal age, with ultrasound diagnosis of GM-IVH.
Data Collection And Analysis:
For each of the included trials, two review authors independently planned to extract data (e.g. number of participants, birth weight, gestational age, type and source of MSCs, other stem cell-based interventions) and assess the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). Primary outcomes considered in this review are all-cause neonatal mortality, major neurodevelopmental disability, GM-IVH, and extension of pre-existing non-severe GM-IVH. We planned to use the GRADE approach to assess the quality of evidence.
Main Results:
Our search strategy yielded 769 references. We did not find any completed studies for inclusion. One randomised controlled trial is currently registered and ongoing. Five phase 1 trials are described in the excluded studies.
Authors' Conclusions:
Currently no evidence is available to show the benefits or harms of stem cell-based interventions for treatment or prevention of GM-IVH in preterm infants.
