Rudnicki Jacek, Kawa Miłosz Piotr, Kotowski Maciej, Michalczyk Barbara, Ustianowski Przemysław, Czajka Ryszard, Machaliński Bogusław
Department of Humanities in Medicine, Pomeranian Medical University in Szczecin, 70-111 Szczecin, Poland.
Exp Clin Transplant. 2015 Dec;13(6):563-72.
This is a preliminary, single-center, prospective study in the field of autologous cord blood transplant. We investigated the feasibility, safety, and tolerability of autologous whole cord blood transplant in extremely premature infants as a potential therapeutic modality to prevent developing complications related to prematurity.
This preliminary prospective study (ClinicalTrials.gov identifier NCT02050971) included preterm infants born at less than 32 weeks of gestational age who developed anemia because of prematurity. Infants were assigned to 2 groups: (1) those receiving an autologous cord blood transfusion within 5 days postpartum (n = 5) and (2) those who obtained only an allogeneic red blood cell transfusion when necessary (n = 9; control group). Vital measurements were performed during and after transfusion, and peripheral blood pH, hematocrit, glucose, and calcium and potassium ion levels were measured over the next 4 days.
Oxygen saturation was significantly increased throughout the cord blood transfusion and in the subsequent 48 hours. No significant differences were found in vital measurements, such as arterial blood pressure (mean, systolic, and diastolic) or heart rate over the first 48 hours posttransfusion. Similarly, no significant differences were found in biochemical analyses of blood with the exception of pH level. We found initial pH level to be significantly augmented in the cord blood recipient group by the first day after transplant, which remained significantly higher for next 24 hours compared with that shown in the control group.
Collection, preparation, and short-term storage of unfrozen cord blood are feasible for clinical use. Our results showed general safety and tolerability of the procedure of whole autologous cord blood transplant in recruited preterm newborns. However, because our study group was small, these results need to be confirmed in further investigations with a larger patient cohort.
这是一项在自体脐带血移植领域开展的初步、单中心、前瞻性研究。我们调查了自体全脐带血移植用于极早产儿作为预防与早产相关并发症的潜在治疗方式的可行性、安全性和耐受性。
这项初步前瞻性研究(ClinicalTrials.gov标识符NCT02050971)纳入了孕周小于32周因早产而发生贫血的早产儿。婴儿被分为两组:(1)产后5天内接受自体脐带血输血的婴儿(n = 5);(2)仅在必要时接受异体红细胞输血的婴儿(n = 9;对照组)。在输血期间和输血后进行生命体征测量,并在接下来的4天内测量外周血pH值、血细胞比容、葡萄糖以及钙和钾离子水平。
在整个脐带血输血期间及随后48小时内,血氧饱和度显著升高。输血后最初48小时内,在诸如动脉血压(平均压、收缩压和舒张压)或心率等生命体征测量方面未发现显著差异。同样,除pH值水平外,血液生化分析未发现显著差异。我们发现,脐带血接受组在移植后第一天初始pH值水平显著升高,与对照组相比,在接下来的24小时内仍显著更高。
未冷冻脐带血的采集、制备和短期储存用于临床是可行的。我们的结果显示了在招募的早产新生儿中进行全自体脐带血移植程序的总体安全性和耐受性。然而,由于我们的研究组规模较小,这些结果需要在更大患者队列的进一步研究中得到证实。