Tissue Donation for Myoblast Culture | NCT01119820

Studies
Tissue Donation for Myoblast Culture

NCT01119820

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Mar 4, 2019Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Observe in Vitro Characteristics of Muscle Tissue
Elective Obstetric or Gynecologic Surgery

Interventions

Tissue Donation

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

Mar 2019

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

Oct 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Jun 2012Actual

First Submitted Date

May 6, 2010

First Submission Date that Met QC Criteria

May 6, 2010

First Posted Date

May 10, 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

Mar 1, 2019

Last Update Posted Date

Mar 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Felicia Lane, Associate Professor, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Not provided

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

Analyze human skeletal muscle and learn more about the ability of adult muscle to produce myoblasts (young muscle cells).

Detailed Description

Study the ability of healthy human skeletal muscle to produce myoblasts, and to determine how many cells would be needed to regenerate a certain section of injured muscle. As part of this research, we hope to gain a better understanding of the effect of age on muscle and how normal skeletal muscle can regenerate itself by producing myoblasts. The information gathered from this study will be specifically used in future research for treating Anal Incontinence.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tissue Donation	Experimental	This study will involve females over 18 who are scheduled to undergo elective surgery. These patients will be screened for participation in this study, which will only involve the collection of discarded tissue.	Other: Tissue Donation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue Donation	Other	Females over 18 who are scheduled to undergo elective surgery will have discarded tissue collected.	Tissue Donation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cell expansion	The goal of this pilot study is to obtain small amounts of human skeletal muscle that would normally be discarded during gynecologic surgery and instead conserve this tissue for laboratory analysis.	weekly

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Age: 18 years of age or older Female Patients who are already electing to undergo obstetric or gynecologic surgery (either vaginal or abdominal) for a preexisting condition.

Exclusion Criteria:

- Active systemic or pelvic infections including HIV HBV HCV, STD, PID Patients with tumors, metastatic disease or treated with cytostatics Patients undergoing emergency surgical procedures Unconscious or mentally incapable to consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felicia Lane, MD	UCI Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCI Women's Healthcare		Orange	California	92868	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009927	Tissue and Organ Procurement

Ancestor Terms

ID	Term
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided