Clinical trial NCT01963455: Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency
Official title: The Effect Evaluation of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Urinary Incontinency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress Incontinency
Keywords: transplantation autologous stress urinary incontinence
muscle derived cells
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-10-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24hours voiding diary reduction
timeFrame: 1month
Secondary outcomes:
measure: Enhance incontinence quality of life (I-Qol)
timeFrame: 1 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology Research Center, Shahid Beheshti University
name: Farzaneh Sharifiaghdas, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
name: Reza Moghadasali, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Farzam Tajali, MD
role: PRINCIPAL_INVESTIGATOR
References: