Tissue Donation for Myoblast Culture

Not Applicable

Completed

• Conditions: Elective Obstetric or Gynecologic Surgery; Observe in Vitro Characteristics of Muscle Tissue
• Interventions: Other: Tissue Donation

• Registration Number: NCT01119820
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2010-02
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-10
• Study Completion: 2012-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tissue Donation	Tissue Donation	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.

Primary Outcome Measures

Name	Time	Method
cell expansion	weekly	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.

Trial Locations

Locations (1)

UCI Women's Healthcare; 🇺🇸 Orange, California, United States