Mesenchymal Stem Cells; Donor and Role in Management and... | NCT01626625

Studies
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture

NCT01626625

Sponsor

Indonesia University

Status

Unknown status

Last Update Posted

Jun 25, 2012Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Healing of Fracture

Interventions

stem cells + hydroxy apatite
autograft taken from iliac crest

Countries

Indonesia

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 2012

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

Apr 2010

Primary Completion Date

Apr 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 22, 2012

First Posted Date

Jun 25, 2012Estimated

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 22, 2012

Last Update Posted Date

Jun 25, 2012Estimated

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 investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stem cells	Experimental	stem cells + hydroxy apatite	Drug: stem cells + hydroxy apatite
autograft	Active Comparator		Other: autograft taken from iliac crest

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stem cells + hydroxy apatite	Drug	patient will be transplanted with stem cells and hydroxyapatite	stem cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
healing of fracture	radiological union	1 year

Secondary Outcomes

Measure	Description	Time Frame
VAS	visual analogue scale	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

athropic nonunion fracture of the long bone

Exclusion Criteria:

immunocompromise,
active infection,
pathological fracture,
ongoing hormonal therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Phedy Phe, MD	Contact			phedy@yahoo.com
Ismail HD, PhD	Contact			phedy2@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RSCM	Recruiting	Jakarta			Indonesia