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

Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Shenzhen Zhongxing Yangfan Biotech Co. Ltd..   Recruitment status was  Recruiting

First Received on November 14, 2006.  
Last Updated on November 7, 2008  
History of Changes
Sponsor: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Collaborators: The 12th Guangzhou Municipal Hospital
Liu Hua Qiao Hospital
Information provided by: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
ClinicalTrials.gov Identifier: NCT00399971
  Purpose

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 Intervention Phase
Anemia, Aplastic Procedure: Ex Vivo Immunotherapy
Drug: Ex vivo immunotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia

Resource links provided by NLM:

Further study details as provided by Shenzhen Zhongxing Yangfan Biotech Co. Ltd.:

Primary Outcome Measures:

  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Hematological Parameters [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hematopoietic Activities in Bone Marrow [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2002
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 14, 2006
Last Updated: November 7, 2008
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2012

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