search
Back to results

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

Primary Purpose

Anemia, Aplastic

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ex Vivo Immunotherapy
Ex vivo immunotherapy
Sponsored by
Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Aplastic focused on measuring Idiopathic Aplastic Anemia, Has Failed Conventional Immunosuppressive Therapy, Not Eligible For Bone Marrow Transplantation, C15.378.071.085

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Hematology, Liu Hua Qiao HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemathera

Arm Description

Patients will receive cell-based immunotherapy.

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Hematological Parameters
Hematopoietic Activities in Bone Marrow
Quality of Life

Full Information

First Posted
November 14, 2006
Last Updated
November 7, 2008
Sponsor
Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Collaborators
The 12th Guangzhou Municipal Hospital, Liu Hua Qiao Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00399971
Brief Title
Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
Official Title
Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Collaborators
The 12th Guangzhou Municipal Hospital, Liu Hua Qiao Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Aplastic
Keywords
Idiopathic Aplastic Anemia, Has Failed Conventional Immunosuppressive Therapy, Not Eligible For Bone Marrow Transplantation, C15.378.071.085

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemathera
Arm Type
Experimental
Arm Description
Patients will receive cell-based immunotherapy.
Intervention Type
Procedure
Intervention Name(s)
Ex Vivo Immunotherapy
Other Intervention Name(s)
Aplastic Anemia, ex vivo Immunotherapy
Intervention Description
Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week
Intervention Type
Drug
Intervention Name(s)
Ex vivo immunotherapy
Other Intervention Name(s)
Aplastic Anemia, ex vivo Immunotherapy
Intervention Description
i.v. infusions, once a week, at least 6 to 12 months
Primary Outcome Measure Information:
Title
Survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Hematological Parameters
Time Frame
2 years
Title
Hematopoietic Activities in Bone Marrow
Time Frame
2 years
Title
Quality of Life
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demao Yang, PhD
Phone
86 755 2603 1580
Email
dyang@yangfan-biotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuiqing Chen, BS
Phone
86 755 2603 1560
Email
info@yangfan-biotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demao Yang, PhD
Organizational Affiliation
Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Hematology, Liu Hua Qiao Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
50010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xiao, MD, PhD
Phone
86 1390 221 3175
First Name & Middle Initial & Last Name & Degree
Yang Gao, MD
Phone
86 1355 618 0868
First Name & Middle Initial & Last Name & Degree
Jiayu Chen, MD
First Name & Middle Initial & Last Name & Degree
Yang Xiao, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
14594507
Citation
Chen J, Liu W, Wang X, Chen H, Wu J, Yang Y, Wu L, Yang D. Ex vivo immunotherapy for patients with benzene-induced aplastic anemia. J Hematother Stem Cell Res. 2003 Oct;12(5):505-14. doi: 10.1089/152581603322448213.
Results Reference
background
PubMed Identifier
16000962
Citation
Li G, Wang X, Wu L, Zhang W, Chen H, Xie Y, Yang D. Ex vivo activated immune cells promote survival and stimulate multilineage hematopoietic recovery in myelosuppressed mice. J Immunother. 2005 Jul-Aug;28(4):420-5. doi: 10.1097/01.cji.0000170360.99714.3f.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs