| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
collection of PBMC from healthy donors
|
Procedure: collection of peripheral blood mononuclear cells from healthy volunteers
|
| 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 | |||||
|---|---|---|---|---|---|
| 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.
|
||||
| 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 |
||||
| 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 |
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