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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399971

Enrollment

100

Registered

2006-11-15

Start date

2002-11-30

Completion date

2009-12-31

Last updated

2008-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Aplastic

Keywords

Idiopathic Aplastic Anemia, Has Failed Conventional Immunosuppressive Therapy, Not Eligible For Bone Marrow Transplantation, C15.378.071.085

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.

Interventions

PROCEDUREEx Vivo Immunotherapy

Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week

DRUGEx vivo immunotherapy

i.v. infusions, once a week, at least 6 to 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Survival	2 years

Secondary

Measure	Time frame
Hematological Parameters	2 years
Hematopoietic Activities in Bone Marrow	2 years
Quality of Life	2 years

Countries

China

Contacts

Primary ContactDemao Yang, PhD

dyang@yangfan-biotech.com86 755 2603 1580

Backup ContactShuiqing Chen, BS

info@yangfan-biotech.com86 755 2603 1560

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026