Umbilical Cord Mesenchymal Stem Cells Infusion for Initia... | NCT01219465

Studies
Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

NCT01219465

Sponsor

Qingdao University

Status

Unknown status

Last Update Posted

Oct 13, 2010Estimated

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

Diabetes Mellitus
Diabetes Mellitus, Type 1
Mesenchymal Stem Cells
Umbilical Cord

Interventions

umbilical cord mesenchymal stem cells

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Oct 12, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

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

Oct 12, 2010

Last Update Posted Date

Oct 13, 2010Estimated

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

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Detailed Description

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
umbilical cord mesenchymal stem cells	Experimental	Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells	Biological: umbilical cord mesenchymal stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
umbilical cord mesenchymal stem cells	Biological	Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.	umbilical cord mesenchymal stem cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
C peptide release test		3 months

Secondary Outcomes

Measure	Description	Time Frame
Exogenous insulin dose		3 months
blood glucose		3 months
glycosylated Hemoglobin A1c

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria:

diabetic ketoacidosis.
evidence of retinopathy at baseline.
Body Mass Index >30.
Severe or acute organ damage.
Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
Severe psychiatric disorder.
Presence of malignancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yangang Wang, MD Phd	The Affiliated Hospital of Qingdao University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stem Cell Research Center of Medical School Hospital of Qingdao University		Qingdao	Shandong	266003	China

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided