Allogeneic Cell Therapy Applications in Neonates: A Systematic Review.

Area of Science:

• Neonatal Medicine
• Regenerative Medicine
• Cell Therapy

Background:

• Neonatal cell therapy is expanding, but evidence for allogeneic cell therapy remains limited.
• This systematic review addresses the safety, feasibility, and efficacy of allogeneic cell therapy in neonates.

Purpose of the Study:

• To systematically review and summarize existing evidence on allogeneic cell therapy in term and preterm neonates.
• To identify safety concerns, feasibility aspects, and efficacy data for various cell types and neonatal conditions.

Main Methods:

• Comprehensive literature search across major databases (Cochrane, Embase, Ovid Medline) and clinical trial registries.
• Independent article selection, data extraction, and risk of bias assessment by two authors.
• Inclusion of 12 published studies (153 infants) and data from 21 ongoing studies.

Main Results:

• Mesenchymal stromal cells (MSCs) from umbilical cord blood (UCB) were the predominant cell type used.
• Primary applications included bronchopulmonary dysplasia (BPD), Krabbe disease, and hypoxic-ischaemic encephalopathy.
• Most studies reported no serious adverse events (SAEs); however, graft-versus-host disease (GVHD) and transient cardiorespiratory compromise were reported in a few cases.

Conclusions:

• Allogeneic cell therapy, particularly with MSCs, appears safe and feasible in neonates.
• Further safety data are needed for non-MSC cell types, and the risk of GVHD requires thorough investigation.
• Robust efficacy data are currently lacking across all investigated cell types and neonatal conditions.