Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency

May 5, 2015 updated by: Royan Institute

The Effect Evaluation of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Urinary Incontinency

This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for the treatment of stress urine incontinency (SUI) in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will be assessed the 12-month safety and potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 10 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 30×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Stress Urinary Incontinence symptoms
  • Urodynamic stress incontinence confirmed with multichannel urodynamic testing
  • positive cough stress test
  • urgency score < stress score
  • Patient's age between 40 - 65 years
  • Desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of SUI

Exclusion Criteria:

  • Post-void residual volume >100cc
  • Detrusor overactivity on preoperative multichannel urodynamic testing
  • History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
  • Desires future childbearing
  • Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative
  • History of bleeding diathesis or current anti-coagulation therapy
  • Inguinal lymphadenopathy or inguinal/vulvar mass
  • Current genitourinary fistula or urethral diverticulum
  • Current sever cystocele or rectocele
  • Active urinary infection
  • Non-treated urge incontinency or any significant voiding dysfunction
  • Neuromuscular disorders
  • Uncontrolled Diabetes
  • Reversible cause of incontinence (i.e. drug effect)
  • Contraindications for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MDCs transplant
The women who have stress urinary incontinency.
Biological: paraurethral injection of MDCs
MDCs transplantation by paraurethral injection .
Other Names:
  • MDCs transplantion by paraurethral injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24hours voiding diary reduction
Time Frame: 1month
Evaluation the 24hours voiding diary reduction by patient questionaire 2h pad test and By clinical measures by cystourethroscopy and urodynamic before , 1, 3,6 and 12 months after MDCs injection.
1month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enhance incontinence quality of life (I-Qol)
Time Frame: 1 month
Evaluation the enhance incontinence quality of life (I-Qol) by questionnaire form, before injection of MDCs, 1, 3,6 and 12 months after injection.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Director: Nasser Aghdami, MD,PhD, Head of Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
  • Study Director: Farzaneh Sharifiaghdas, MD, Urology and Nephrology Research Center, Shahid Beheshti University
  • Principal Investigator: Farzam Tajali, MD, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • royan-Kidney-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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