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

NCT00399971 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-11-11

No results posted yet for this study

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.

Conditions

  • Anemia, Aplastic

Interventions

PROCEDURE

Ex Vivo Immunotherapy

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

DRUG

Ex vivo immunotherapy

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

Sponsors & Collaborators

  • The 12th Guangzhou Municipal Hospital

    collaborator UNKNOWN

  • Liu Hua Qiao Hospital

    collaborator UNKNOWN

  • Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Demao Yang, PhD · Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399971 on ClinicalTrials.gov