Viewing Study NCT00399971



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00399971
Status: UNKNOWN
Last Update Posted: 2008-11-11
First Post: 2006-11-14

Brief Title: Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
Sponsor: Shenzhen Zhongxing Yangfan Biotech Co Ltd
Organization: Shenzhen Zhongxing Yangfan Biotech Co Ltd

Study Overview

Official Title: Phase III Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
Status: UNKNOWN
Status Verified Date: 2008-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Our hypothesis is that ex vivo activated immune cells would produce multiple known and unknown potent hematopoietic cytokines working in concert these cytokines help stem cell growth and differentiation Additionally these cells travel and home to bone marrow as well as spleen and liver involved in hematopoietic activities where direct cell-cell contact may be beneficial
Detailed Description: Patients will be required to stay in our hospitals to receive the immunotherapy Allogeneic peripheral blood mononuclear cells from healthy donors and the autologous peripheral mononuclear cells will alternately used for the treatment Patients are expected to spend at least 6 to 12 months in the hospital and wont be released until they have improved significantly

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None