NCT02156934

CompletedPhase 2

Paraurethral Transplantation of Autologous Muscle Derived St...

Royan Institute Source

Royan Institute

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Royan-Kidney-002

Study Type

interventional

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: December 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 2, 2014
Actual (reported)
First Posted
June 5, 2014
Actual (reported)
Primary Completion
December 2015
Actual (reported)
Study Completion
December 2015
Actual (reported)

Last Updated: December 4, 2015
Status Verified: October 2013
Last Update Submitted: December 3, 2015

Conditions

Stress Urine Incontinency

Keywords

autologous stress urinary incontinence muscle derived cells

Outcome Measures

Primary Outcomes (1)

24hr voiding diary reduction
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
1 month

Secondary Outcomes (1)

incontinence quality of life (I-Qol)
1month

Study Arms (1)

Muscle derived stem cell

EXPERIMENTAL

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

Biological: paraurethral injection

Interventions

paraurethral injectionBiological

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

Muscle derived stem cell

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 60 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Female
Stress Urinary Incontinence symptoms

Sponsors & Collaborators

Royan Institute
Governmentlead

Study Sites (1)

Royan Institute

Tehran, Iran

Study Officials

Hamid Gourabi, PhD
Head of Royan Institute
STUDY CHAIR
Nasser Aghdami, MD,PhD
Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute
STUDY DIRECTOR
Farzaneh Sharifiaghdas, MD
Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
STUDY DIRECTOR
Farshad Zohrabi, MD
Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 5, 2014

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Reza Moghadasali, PhD

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

PRINCIPAL INVESTIGATOR

Primary Completion

December 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

Last Updated

December 4, 2015

Record last verified: 2013-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02156934
Data provider: ClinicalTrials.gov
Source updated: 2015-12-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:26 UTC

Locations

IR(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Muscle derived stem cell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Muscle derived stem cell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations