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

November 7, 2008 updated by: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Hematological Parameters
Time Frame: 2 years
2 years
Hematopoietic Activities in Bone Marrow
Time Frame: 2 years
2 years
Quality of Life
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Collaborators

The 12th Guangzhou Municipal Hospital
Liu Hua Qiao Hospital

Investigators

  • Study Chair: Demao Yang, PhD, Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (Estimate)

November 15, 2006

Study Record Updates

Last Update Posted (Estimate)

November 11, 2008

Last Update Submitted That Met QC Criteria

November 7, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAFocus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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