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

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ClinicalTrials.gov Identifier: NCT00399971
Recruitment Status : Unknown
Verified November 2008 by Shenzhen Zhongxing Yangfan Biotech Co. Ltd..
Recruitment status was:  Recruiting
First Posted : November 15, 2006
Last Update Posted : November 11, 2008
Sponsor:
Collaborators:
Information provided by:

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
Anemia, Aplastic Procedure: Ex Vivo Immunotherapy Drug: Ex vivo immunotherapy 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
Study Start Date : November 2002
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Aplastic Anemia, ex vivo Immunotherapy
Drug: Ex vivo immunotherapy
i.v. infusions, once a week, at least 6 to 12 months
Other Name: Aplastic Anemia, ex vivo Immunotherapy


Outcome Measures

Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Hematological Parameters [ Time Frame: 2 years ]
  2. Hematopoietic Activities in Bone Marrow [ Time Frame: 2 years ]
  3. Quality of Life [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399971


Contacts
Contact: Demao Yang, PhD 86 755 2603 1580 dyang@yangfan-biotech.com
Contact: Shuiqing Chen, BS 86 755 2603 1560 info@yangfan-biotech.com

Locations
China, Guangdong
Department of Hematology, Liu Hua Qiao Hospital Recruiting
Guangzhou, Guangdong, China, 50010
Contact: Yang Xiao, MD, PhD    86 1390 221 3175      
Contact: Yang Gao, MD    86 1355 618 0868      
Principal Investigator: Jiayu Chen, MD         
Principal Investigator: Yang Xiao, MD, PhD         
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.
More Information

Publications:
Responsible Party: Demao Yang/Chief Scientist, Zhongxing Yangfan Biotech Co. Ltd.
ClinicalTrials.gov Identifier: NCT00399971     History of Changes
Other Study ID Numbers: AAFocus
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: November 11, 2008
Last Verified: November 2008

Keywords provided by Shenzhen Zhongxing Yangfan Biotech Co. Ltd.:
Idiopathic Aplastic Anemia
Has Failed Conventional Immunosuppressive Therapy
Not Eligible For Bone Marrow Transplantation
C15.378.071.085

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases