دورية أكاديمية
أعرض في EDS

Maintenance of the synergistic effects of cord blood cells and erythropoietin combination therapy after additional cord blood infusion in children with cerebral palsy: 1-year open-label extension study of randomized placebo-controlled trial.

التفاصيل البيبلوغرافية
العنوان: Maintenance of the synergistic effects of cord blood cells and erythropoietin combination therapy after additional cord blood infusion in children with cerebral palsy: 1-year open-label extension study of randomized placebo-controlled trial.
المؤلفون: Suh MR; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea.; Rehabilitation and Regeneration Research Center, CHA University, Pocheon, Republic of Korea., Min K; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea.; Rehabilitation and Regeneration Research Center, CHA University, Pocheon, Republic of Korea., Cho KH; Rehabilitation and Regeneration Research Center, CHA University, Pocheon, Republic of Korea.; Department of Rehabilitation Medicine, CHA Ilsan Medical Center, CHA University School of Medicine, Goyang, Republic of Korea., Kim J; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea.; Rehabilitation and Regeneration Research Center, CHA University, Pocheon, Republic of Korea., Lim I; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea.; Rehabilitation and Regeneration Research Center, CHA University, Pocheon, Republic of Korea., Park M; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea., Noh EM; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea., Kim MY; Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-Ro, Bundang-Gu, Seongnam, Gyeonggi-Do, Republic of Korea. kmin@cha.ac.kr.; Rehabilitation and Regeneration Research Center, CHA University, Pocheon, Republic of Korea. kmin@cha.ac.kr.
المصدر: Stem cell research & therapy [Stem Cell Res Ther] 2023 Dec 12; Vol. 14 (1), pp. 362. Date of Electronic Publication: 2023 Dec 12.
نوع المنشور: Randomized Controlled Trial; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101527581 Publication Model: Electronic Cited Medium: Internet ISSN: 1757-6512 (Electronic) Linking ISSN: 17576512 NLM ISO Abbreviation: Stem Cell Res Ther Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central
مواضيع طبية MeSH: Cerebral Palsy*/drug therapy , Erythropoietin*/therapeutic use, Child ; Infant ; Humans ; Fetal Blood ; Blood Cells ; Combined Modality Therapy ; Treatment Outcome
مستخلص: Background: This 1-year open-label extension study aimed to identify the persistent synergistic effects of allogeneic umbilical cord blood (UCB) cells and erythropoietin (EPO) in children with cerebral palsy (CP) for up to 2 years.
Methods: This open-label extension study followed children with CP who were enrolled in the previous randomized, double blind, placebo-controlled trial. The following groups from the first trial were maintained: (A) UCB + EPO, (B) UCB, (C) EPO, and (D) only placebo, and all the participants had continued active rehabilitation. This extended study started 3 months after termination of the first trial, which had a 1-year follow-up duration. All subjects received single additional UCB intravenous infusion at the extension baseline regardless of their initial allocation. Outcome measures were the gross motor performance measure (GMPM), gross motor function measure-66 (GMFM-66), and Bayley scales of infant development-II (BSID-II), which were followed at 3, 6, and 12 months after the extension baseline. Changes in the outcome scores from the baseline values of the previous trial and this study were analysed.
Results: Sixty-nine children (4.29 ± 1.28 years, M:F = 34:35) were included in this study. Each group showed improvements in the outcome measures at 12 months after additional UCB infusion compared to the baseline scores, except for GMFM and GMPM in Group C which were elevated at 3 and 6 months post-therapy. Total subject analyses did not show significant differences in the outcome measures between the four different groups at 3, 6 and 12 months after additional UCB therapy. However, patients with severe dysfunction, whose GMFCS levels were IV and V, revealed a larger improvement of the GMPM score in Group A than in Group D (Ps < 0.05) from the baseline value of the previous trial. The changes in BSID-II mental scale scores were positively correlated with the number of administered total nucleated cells per unit body weight during this one-year extension study period (r = 0.536, P = 0.001).
Conclusions: These results suggest that when administering UCB to treat patients with CP, combination therapy with EPO is more effective, and the effect might last as long as 2 years, especially in patients with severe impairments.
Trial Registration: CHA Bundang Medical Center IRB, No. 2015-06-093, approved on July 29, 2015, ( https://www.e-irb.com:3443/devlpg/nlpgS200.jsp ), ClinicalTrials.gov, NCT03130816, retrospectively registered on April 27, 2017 ( https://clinicaltrials.gov/ct2/show/NCT03130816?term=NCT03130816&draw=2&rank=1 ).
(© 2023. The Author(s).)
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معلومات مُعتمدة: HI16C1559 Korea Health Technology R&D project through the Korea Health Industry Development Institute (KHIDI), Ministry of Health and Welfare, Republic of Korea
فهرسة مساهمة: Keywords: Cerebral palsy; Clinical trial; Erythropoietin; Functional performance; Umbilical cord blood
سلسلة جزيئية: ClinicalTrials.gov NCT03130816
المشرفين على المادة: 11096-26-7 (Erythropoietin)
تواريخ الأحداث: Date Created: 20231213 Date Completed: 20231216 Latest Revision: 20240125
رمز التحديث: 20240126
مُعرف محوري في PubMed: PMC10717973
DOI: 10.1186/s13287-023-03600-4
PMID: 38087394
قاعدة البيانات: MEDLINE
الوصف
تدمد:1757-6512
DOI:10.1186/s13287-023-03600-4