MedDataX Logo

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

NCT ID: NCT00399971

Last Updated: 2008-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia, Aplastic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemathera

Patients will receive cell-based immunotherapy.

Group Type EXPERIMENTAL

Ex Vivo Immunotherapy

Intervention Type PROCEDURE

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

Ex vivo immunotherapy

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ex Vivo Immunotherapy

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

Intervention Type PROCEDURE

Ex vivo immunotherapy

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aplastic Anemia, ex vivo Immunotherapy Aplastic Anemia, ex vivo Immunotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The 12th Guangzhou Municipal Hospital

UNKNOWN

Sponsor Role collaborator

Liu Hua Qiao Hospital

UNKNOWN

Sponsor Role collaborator

Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhongxing Yangfan Biotech Co. Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Demao Yang, PhD

Role: STUDY_CHAIR

Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Hematology, Liu Hua Qiao Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Demao Yang, PhD

Role: CONTACT

Phone: 86 755 2603 1580

Email: [email protected]

Shuiqing Chen, BS

Role: CONTACT

Phone: 86 755 2603 1560

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yang Xiao, MD, PhD

Role: primary

Yang Gao, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14594507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16000962 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAFocus

Identifier Type: -

Identifier Source: org_study_id