Clinical Trial: Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
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 Summary: 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.
Sponsor: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Current Primary Outcome: Survival [ Time Frame: 2 years ]
Original Primary Outcome: Survival
Current Secondary Outcome:
- Hematological Parameters [ Time Frame: 2 years ]
- Hematopoietic Activities in Bone Marrow [ Time Frame: 2 years ]
- Quality of Life [ Time Frame: 2 years ]
Original Secondary Outcome:
- Hematological Parameters
- Hematopoietic Activities in Bone Marrow
- Quality of Life
Information By: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Dates:
Date Received: November 14, 2006
Date Started: November 2002
Date Completion: December 2009
Last Updated: November 7, 2008
Last Verified: November 2008
