Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2002
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedNovember 11, 2008
November 1, 2008
6.6 years
November 14, 2006
November 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
2 years
Secondary Outcomes (3)
Hematological Parameters
2 years
Hematopoietic Activities in Bone Marrow
2 years
Quality of Life
2 years
Study Arms (1)
Hemathera
EXPERIMENTALPatients will receive cell-based immunotherapy.
Interventions
Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week
Eligibility Criteria
You may qualify if:
- Clinical Diagnosis of Idiopathic Aplastic Anemia
- Not Eligible for Bone Marrow Transplantation
- Not Responsive to Conventional Immunosuppressive Therapy
You may not qualify if:
- Leukemia or MDS or PNH or Fanconi's Disease
- pregnancy
- Allergic to Blood Product
- Severe Hypertension or Heart Disease
- Liver or Kidney Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shenzhen Zhongxing Yangfan Biotech Co. Ltd.lead
- The 12th Guangzhou Municipal Hospitalcollaborator
- Liu Hua Qiao Hospitalcollaborator
Study Sites (1)
Department of Hematology, Liu Hua Qiao Hospital
Guangzhou, Guangdong, 50010, China
Related Publications (2)
Chen J, Liu W, Wang X, Chen H, Wu J, Yang Y, Wu L, Yang D. Ex vivo immunotherapy for patients with benzene-induced aplastic anemia. J Hematother Stem Cell Res. 2003 Oct;12(5):505-14. doi: 10.1089/152581603322448213.
PMID: 14594507BACKGROUNDLi G, Wang X, Wu L, Zhang W, Chen H, Xie Y, Yang D. Ex vivo activated immune cells promote survival and stimulate multilineage hematopoietic recovery in myelosuppressed mice. J Immunother. 2005 Jul-Aug;28(4):420-5. doi: 10.1097/01.cji.0000170360.99714.3f.
PMID: 16000962BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Demao Yang, PhD
Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
November 1, 2002
Primary Completion
June 1, 2009
Study Completion
December 1, 2009
Last Updated
November 11, 2008
Record last verified: 2008-11