Tissue Donation for Myoblast Culture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01119820
First received: May 6, 2010
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Observe in Vitro Characteristics of Muscle Tissue
Elective Obstetric or Gynecologic Surgery
Other: Tissue Donation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Tissue Donation for Myoblast Culture

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • cell expansion [ Time Frame: weekly ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: October 2008
Study Completion Date: June 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Tissue Donation
Females over 18 who are scheduled to undergo elective surgery will have discarded tissue collected.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119820

Locations
United States, California
UCI Women's Healthcare
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Felicia Lane, MD UCI Medical Center
  More Information

No publications provided

Responsible Party: Felicia Lane, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01119820     History of Changes
Other Study ID Numbers: 2008-6467
Study First Received: May 6, 2010
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
elective obstetric or gynecologic surgery

ClinicalTrials.gov processed this record on July 24, 2014