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Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration.

ABSTRACT: Umbilical cord blood (UCB) is proving to be a valuable resource of stem cells and is currently being used for a variety of oncological and hematological pathologies and metabolic disorders; in addition, new clinical trials are showing promising results in certain neurological, autoimmune and developmental disorders. More recently, the US Food and Drug Administration (FDA) has granted approval for the clinical use of cellular therapies with UCB-based products and new therapeutic utilizations are being studied for regenerative medicine; all these developments will increase the utilization of "off-the-shelf" UCB units. As a drawback, contamination of UCB grafts is a significant occurrence (upwards of 5% in most analysis) and, even though it consists mainly of non-pathogenic bacteria, it can raise serious questions regarding intravenous UCB administration, especially in patients who are not receiving coincidental antibiotic coverage. Here we report the successful decontamination of two UCB grafts prior to administration without compromising the viability of the stem cells administered, and propose to apply the same principle and procedure to any contaminated graft.

SUBMITTER: Stancioiu F

PROVIDER: S-EPMC9923064 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration.

Stancioiu Felician F Bogdan Raluca R Bulumac Bogdan B Ivanescu Bogdan B Dumitrescu Radu R

Maedica 20221201 4

Umbilical cord blood (UCB) is proving to be a valuable resource of stem cells and is currently being used for a variety of oncological and hematological pathologies and metabolic disorders; in addition, new clinical trials are showing promising results in certain neurological, autoimmune and developmental disorders. More recently, the US Food and Drug Administration (FDA) has granted approval for the clinical use of cellular therapies with UCB-based products and new therapeutic utilizations are ...[more]

PMID: 36818273

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Project description:BackgroundCurrently, the treatment of anemia in preterm infants is based on packed red blood cell (RBC) transfusions from adult donors. Oxygen (O2) is mainly transported to the tissues bound to hemoglobin (Hb). In extremely low gestational age neonates (ELGANs), fetal hemoglobin (HbF), which has a higher affinity for O2, represents up to 95% of circulating hemoglobin. During the first month of life, the majority of ELGANs will require an adult-donor RBC transfusion causing HbF levels to rapidly drop. HbA releases 50% more oxygen in peripheral tissues than HbF. Increased release of O2 in the retina is one of the main factors related to the development of retinopathy of prematurity (ROP). Collecting umbilical cord blood and using autologous umbilical cord whole blood (UCB) transfusions would contribute to maintaining physiological HbF concentrations in newborns and avoid oxygen-in-excess derived damage.MethodsThis is a randomized, double-blinded, multicenter clinical trial. ELGANs ≤28 weeks of gestational age will be randomized 1:1 to receive an autologous umbilical cord blood transfusion (intervention arm) or standard transfusion of packed RBC from an adult donor (control arm) to assess ROP development. Assuming a 50% reduction in ROP incidence, 134 patients (67 per group) will be recruited. When blood transfusion is indicated, the Blook Bank will supply UCB or RCB according to the patient's group. The primary endpoint is the incidence of any ROP. Secondary endpoints are assessessment of treatment safety, results of biomarkers related to ROP and its chronology, and urine oxidative stress markers. In addition, the cellular composition of umbilical cord blood and its relationship with prematurity-related pathologies will be analyzed. All patients will be followed-up to 24 months of corrected age to evaluate their neurodevelopment.DiscussionROP is a major cause of irreversible blindness in preterm newborns. Transfusions with adult donor blood can lead to complications, including ROP. UCB transfusions offer advantages by maintaining physiological HbF levels and potentially optimizing postnatal development. Moreover, autologous UCB transfusion could reduce risks associated with heterologous blood products, although volume collection remains challenging. UCB contains growth factors and progenitor cells that may impact ROP.

Dataset Information

Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration.

Publications

Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration.

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