Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hemathera Patients will receive cell-based immunotherapy. |
Procedure: Ex Vivo Immunotherapy
Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week
Other Names:
Drug: Ex vivo immunotherapy
i.v. infusions, once a week, at least 6 to 12 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Survival [2 years]
Secondary Outcome Measures
- Hematological Parameters [2 years]
- Hematopoietic Activities in Bone Marrow [2 years]
- Quality of Life [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical Diagnosis of Idiopathic Aplastic Anemia
-
Not Eligible for Bone Marrow Transplantation
-
Not Responsive to Conventional Immunosuppressive Therapy
Exclusion Criteria:
-
Leukemia or MDS or PNH or Fanconi's Disease
-
pregnancy
-
Allergic to Blood Product
-
Severe Hypertension or Heart Disease
-
Liver or Kidney Disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Hematology, Liu Hua Qiao Hospital | Guangzhou | Guangdong | China | 50010 |
Sponsors and Collaborators
- Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
- The 12th Guangzhou Municipal Hospital
- Liu Hua Qiao Hospital
Investigators
- Study Chair: Demao Yang, PhD, Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Li 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.
- AAFocus