Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stress Incontinency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MDCs transplant

The women who have stress urinary incontinency.

Group Type EXPERIMENTAL

paraurethral injection of MDCs

Intervention Type BIOLOGICAL

MDCs transplantation by paraurethral injection .

Interventions

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paraurethral injection of MDCs

MDCs transplantation by paraurethral injection .

Intervention Type BIOLOGICAL

Other Intervention Names

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MDCs transplantion by paraurethral injection.

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No