Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
- Conditions
- Anemia, Aplastic
- Interventions
- Drug: Ex vivo immunotherapy
- Registration Number
- NCT00399971
- Lead Sponsor
- Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
- 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 won't be released until they have improved significantly.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Clinical Diagnosis of Idiopathic Aplastic Anemia
- Not Eligible for Bone Marrow Transplantation
- Not Responsive to Conventional Immunosuppressive Therapy
- Leukemia or MDS or PNH or Fanconi's Disease
- pregnancy
- Allergic to Blood Product
- Severe Hypertension or Heart Disease
- Liver or Kidney Disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hemathera Ex vivo immunotherapy Patients will receive cell-based immunotherapy.
- Primary Outcome Measures
Name Time Method Survival 2 years
- Secondary Outcome Measures
Name Time Method Hematological Parameters 2 years Hematopoietic Activities in Bone Marrow 2 years Quality of Life 2 years
Trial Locations
- Locations (1)
Department of Hematology, Liu Hua Qiao Hospital
🇨🇳Guangzhou, Guangdong, China