CClinicalTrials.gg
Status unknownNCT00399971Updated Nov 11, 2008

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

A Phase 1/2 interventional study of Ex Vivo Immunotherapy and Ex vivo immunotherapy in Anemia, Aplastic, sponsored by Shenzhen Zhongxing Yangfan Biotech Co. Ltd.. Status unknown at 1 site in China. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-11-11.

Sponsored by Shenzhen Zhongxing Yangfan Biotech Co. Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
10 Years to 80 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Anemia, Aplastic

Keywords

  • Idiopathic Aplastic Anemia
  • Has Failed Conventional Immunosuppressive Therapy
  • Not Eligible For Bone Marrow Transplantation
  • C15.378.071.085
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's planned enrollment of 100 is close to the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

This is the only study on the registry with Shenzhen Zhongxing Yangfan Biotech Co. Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical Diagnosis of Idiopathic Aplastic Anemia
  • Not Eligible for Bone Marrow Transplantation
  • Not Responsive to Conventional Immunosuppressive Therapy

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Hemathera

    Patients will receive cell-based immunotherapy.

    Procedure: Ex Vivo Immunotherapy · Drug: Ex vivo immunotherapy

Interventions

  • ProcedureEx Vivo Immunotherapy

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

    Also known as: Aplastic Anemia, ex vivo Immunotherapy

  • DrugEx vivo immunotherapy

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

    Also known as: Aplastic Anemia, ex vivo Immunotherapy

06

What researchers measure

Primary outcomes

  1. Survival

    Time frame: 2 years

Secondary outcomes

  1. Hematological Parameters

    Time frame: 2 years

  2. Hematopoietic Activities in Bone Marrow

    Time frame: 2 years

  3. Quality of Life

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Hematology, Liu Hua Qiao Hospital
    Guangzhou, Guangdong 50010, China
    • Yang Xiao, MD, PhD · Contact · 86 1390 221 3175
    • Yang Gao, MD · Contact · 86 1355 618 0868
    • Jiayu Chen, MD · Principal investigator
    • Yang Xiao, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 14594507 ↗
  • 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. PubMed 16000962 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00399971
Lead sponsor
Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Collaborators
The 12th Guangzhou Municipal Hospital, Liu Hua Qiao Hospital
First posted
Nov 15, 2006
Start date
Nov 2002
Primary completion
Jun 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Nov 11, 2008

Study contacts

Demao Yang, PhD
Contact
dyang@yangfan-biotech.com
86 755 2603 1580
Shuiqing Chen, BS
Contact
info@yangfan-biotech.com
86 755 2603 1560
Demao Yang, PhD
study chair · Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion