Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia

Shenzhen Zhongxing Yangfan Biotech Co.

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Anemia, Aplastic

Treatments: Procedure: Ex Vivo Immunotherapy; Drug: Ex vivo immunotherapy

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00399971

AAFocus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Hemathera

Experimental group

Description:

Patients will receive cell-based immunotherapy.

Treatment:

Drug: Ex vivo immunotherapy

Procedure: Ex Vivo Immunotherapy