MedDataX Logo

Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency

NCT ID: NCT02156934

Last Updated: 2015-12-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urine Incontinency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Muscle derived stem cell

Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.

Group Type EXPERIMENTAL

paraurethral injection

Intervention Type BIOLOGICAL

Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

paraurethral injection

Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute

Farzaneh Sharifiaghdas, MD

Role: STUDY_DIRECTOR

Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences

Farshad Zohrabi, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences

Reza Moghadasali, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royan Institute

Tehran, , Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Related Links

Access external resources that provide additional context or updates about the study.

http://Royaninstitute.org

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Royan-Kidney-002

Identifier Type: -

Identifier Source: org_study_id