NCT06734520|RecruitingDMC
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Sponsor study identifier
interventional
3
1 country
2
Study Start
October 1, 2024
Actual (reported)Primary Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a single-arm, open label, phase 1 study in subjects with beta-thalassemia. This study will evaluate the safety and efficacy of preconditioning-free super-transplantation on beta-thalassemia pediatric patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2024
Actual (reported)November 16, 2024
Actual (reported)December 16, 2024
Actual (reported)July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
chimeric status
Detecting the chimerism in recipients' peripheral blood and bone marrow.Chimerism is generally measured in percentages(%)
1 year after transplantation.
Children with β-thalassemia major received super transplantation, and chimerism tests were performed at 3 months, 6 months, 9 months, and 1 year after transplantation to evaluate the safety and effectiveness.
Haplo-identical donors are mobilized with G-CSF and PBMCs that contain CD34+ stem cells and CD3+ lymphocytes will be extracted by blood cell separators. Then the patients will be infused with the PBMC
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Guangzhou Women and Children's Medical Center Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 51000, China
Guangzhou Women and Children's Medical Center Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Ali S, Mumtaz S, Shakir HA, Khan M, Tahir HM, Mumtaz S, Mughal TA, Hassan A, Kazmi SAR, Sadia, Irfan M, Khan MA. Current status of beta-thalassemia and its treatment strategies. Mol Genet Genomic Med. 2021 Dec;9(12):e1788. doi: 10.1002/mgg3.1788. Epub 2021 Nov 5.
Shafique F, Ali S, Almansouri T, Van Eeden F, Shafi N, Khalid M, Khawaja S, Andleeb S, Hassan MU. Thalassemia, a human blood disorder. Braz J Biol. 2021 Sep 3;83:e246062. doi: 10.1590/1519-6984.246062. eCollection 2021.
Hua Jiang, PHD
Guangzhou Medical University Affiliated Women's and Children's Medical Center
First Submitted
November 16, 2024
First Posted
December 16, 2024
Study Start
October 1, 2024
Actual (reported)Primary Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Dever DP, Bak RO, Reinisch A, Camarena J, Washington G, Nicolas CE, Pavel-Dinu M, Saxena N, Wilkens AB, Mantri S, Uchida N, Hendel A, Narla A, Majeti R, Weinberg KI, Porteus MH. CRISPR/Cas9 beta-globin gene targeting in human haematopoietic stem cells. Nature. 2016 Nov 17;539(7629):384-389. doi: 10.1038/nature20134. Epub 2016 Nov 7.
Study Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 16, 2024
Record last verified: 2024-12
Share IPD with 5th Medical Center ofA General Hospital
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Source: ClinicalTrials.gov.
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