Safety and Efficacy Study of Ex Vivo Immunotherapy for Tr... | NCT00399971

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

NCT00399971

Sponsor

Shenzhen Zhongxing Yangfan Biotech Co. Ltd.

Status

Unknown status

Last Update Posted

Nov 11, 2008Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Anemia, Aplastic

Interventions

Ex Vivo Immunotherapy
Ex vivo immunotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Jun 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Nov 14, 2006

First Submission Date that Met QC Criteria

Nov 14, 2006

First Posted Date

Nov 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2008

Last Update Posted Date

Nov 11, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Shenzhen Zhongxing Yangfan Biotech Co. Ltd.INDUSTRY

Collaborators

Name	Class
The 12th Guangzhou Municipal Hospital	UNKNOWN
Liu Hua Qiao Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemathera	Experimental	Patients will receive cell-based immunotherapy.	Procedure: Ex Vivo Immunotherapy Drug: Ex vivo immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ex Vivo Immunotherapy	Procedure	Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week	Hemathera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival		2 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Demao Yang, PhD	Contact	86 755 2603 1580		dyang@yangfan-biotech.com
Shuiqing Chen, BS	Contact	86 755 2603 1560		info@yangfan-biotech.com

Overall Officials

Name	Affiliation	Role
Demao Yang, PhD	Shenzhen Zhongxing Yangfan Biotech Co. Ltd.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematology, Liu Hua Qiao Hospital	Recruiting	Guangzhou	Guangdong	50010	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14594507	Background	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.
16000962	Background	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.

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000080983	Bone Marrow Failure Disorders