Investigation of Stem Cells in Human Lipoaspirate | NCT01677520

Studies
Investigation of Stem Cells in Human Lipoaspirate

NCT01677520

Sponsor

University of Nevada, Las Vegas

Status

Unknown status

Last Update Posted

Jan 9, 2015Estimated

Enrollment

240Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

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

Jan 2015

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

Mar 2011

Primary Completion Date

Aug 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Aug 28, 2012

First Submission Date that Met QC Criteria

Aug 31, 2012

First Posted Date

Sep 3, 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

Jan 8, 2015

Last Update Posted Date

Jan 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

William A. Zamboni, M.D., Professor and Chair Department of Surgery UNSOM, University of Nevada, Las VegasPrincipal Investigator

Lead Sponsor

University of Nevada, Las VegasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 overall purpose of this study is to enhance identification and isolation of ADSCs and adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts, and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used in aesthetic surgery but tend to disassemble over time. If the investigators can enhance growth and volume of fat in culture, the investigators could use fat grafts in reconstruction of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.

Detailed Description

Not provided

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

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Estimated

Label	Type	Description	Intervention Names
18-30 yrs, 31-50 yrs, 51-70 yrs		No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Viable ADSCs	Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.	Day of Surgery

Secondary Outcomes

Measure	Description	Time Frame
Percent of Apoptotic ADSCs	Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.	Day of Surgery

Other Outcomes

Measure	Description	Time Frame
Percent of Necrotic ADSCs	Percent of necrotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days of refrigerated storage.	Day of Surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study.

Exclusion Criteria:

Pregnant women will be excluded to protect the unborn child.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Primary Care Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
William A Zamboni, M.D.	Contact	702-671-2278		wzamboni@medicine.nevada.edu
Shelley J Williams, M.S.	Contact	702-895-1445		sjwilliams@medicine.nevada.edu

Overall Officials

Name	Affiliation	Role
William A Zamboni, M.D.	UNSOM	Principal Investigator
Wei Z Wang, M.D.	wwang@medicine.nevada.edu	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nevada School of Medicine Patient Care Center	Recruiting	Las Vegas	Nevada	89102	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009336	Necrosis

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided