Condition or disease | Intervention/treatment | Phase |
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Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis | Procedure: collection of peripheral blood mononuclear cells from healthy volunteers | Not Applicable |
The study is a single-center study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products |
Actual Study Start Date : | September 26, 2019 |
Estimated Primary Completion Date : | July 20, 2021 |
Estimated Study Completion Date : | December 20, 2021 |
Arm | Intervention/treatment |
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collection of PBMC from healthy donors
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Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Huayuan Zhu, PhD& MD | +8668306034 | huayuan.zhu@hotmail.com |
China, Jiangsu | |
Hematological Department, People's Hospital of Jiangsu Province | Recruiting |
Nanjing, Jiangsu, China, 210029 | |
Contact: Wei Xu, Ph.D. +86-2568302182 xuwei10000@hotmail.com |
Principal Investigator: | Wei Xu, PhD& MD | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) |
Tracking Information | |||||
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First Submitted Date ICMJE | July 19, 2019 | ||||
First Posted Date ICMJE | July 22, 2019 | ||||
Last Update Posted Date | April 29, 2020 | ||||
Actual Study Start Date ICMJE | September 26, 2019 | ||||
Estimated Primary Completion Date | July 20, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
the number of PBMC [ Time Frame: two year ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products | ||||
Official Title ICMJE | A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products | ||||
Brief Summary | The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and development of allogeneic cellular immunotherapy products. | ||||
Detailed Description |
The study is a single-center study.
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis | ||||
Intervention ICMJE | Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
|
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Study Arms ICMJE | collection of PBMC from healthy donors
Intervention: Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
5 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 20, 2021 | ||||
Estimated Primary Completion Date | July 20, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04027855 | ||||
Other Study ID Numbers ICMJE | BM2L201903 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | WEI XU, The First Affiliated Hospital with Nanjing Medical University | ||||
Study Sponsor ICMJE | The First Affiliated Hospital with Nanjing Medical University | ||||
Collaborators ICMJE | Nanjing Legend Biotechnology Co.,Ltd. | ||||
Investigators ICMJE |
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PRS Account | The First Affiliated Hospital with Nanjing Medical University | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |