NCT00399971

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shenzhen Zhongxing Yangfan Biotech Co. Ltd. · Industry
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: Not accepted

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 won't be released until they have improved significantly.

Conditions

• Anemia, Aplastic

Interventions

Type	Name	Description
PROCEDURE	Ex Vivo Immunotherapy	Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week
DRUG	Ex vivo immunotherapy	i.v. infusions, once a week, at least 6 to 12 months

Timeline

• Start date: 2002-11-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2006-11-15
• Last updated: 2008-11-11

Locations

1 site across 1 country: China