Osteogenic Effects in Human Mesenchymal Stem Cells Enhanc... | NCT01323894

Studies
Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling

NCT01323894

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

Jun 17, 2016Estimated

Enrollment

3Actual

Phase

Not provided

Conditions

Primary Disease

Interventions

Not provided

Countries

Taiwan

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 24, 2011

First Submission Date that Met QC Criteria

Mar 25, 2011

First Posted Date

Mar 28, 2011Estimated

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

Jun 15, 2016

Last Update Posted Date

Jun 17, 2016Estimated

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 first year purpose:

The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Detailed Description

Our previous work is investigating the viral (Adv-BMP-2) administration for the development of a model to generate bones for possible use in clinical settings; the non-viral and viral administrations will be compared for best osteogenesis effects.

The first year purpose:

The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling/Hydroxyapatite Nanoparticles--Comparisons between Non-viral and Viral administration in Tissue Engineered Bone Regeneration	August 2011-July 2013	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age above 10 years old
The patients require surgery ner iliac or abdomen areas

Exclusion Criteria:

age below 10 years old

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

The patients require surgery ner iliac or abdomen areas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sopha Chia-Ning Chang, M.D. Ph.D.	China Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical Universty Hospital		Taichung		404	Taiwan