Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

NCT ID: NCT01648491

Last Updated: 2017-01-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-01-31

Brief Summary

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Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

Detailed Description

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Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Conditions

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Stress Urinary Incontinence

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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Stem Cell treatment

Muscle Biopsy and Injection of autologous stem cells

Group Type EXPERIMENTAL

Muscle Biopsy

Intervention Type PROCEDURE

Biopsy of thigh muscle to obtain stem cell core.

Injection of autologous stem cells

Intervention Type BIOLOGICAL

After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.

Interventions

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Muscle Biopsy

Biopsy of thigh muscle to obtain stem cell core.

Intervention Type PROCEDURE

Injection of autologous stem cells

After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* urinary incontinence
* failed urinary incontinence (UI) treatments
Minimum Eligible Age

78 Years

Maximum Eligible Age

82 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role collaborator

Kenneth Peters, MD

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Peters, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kenneth M Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2011-204

Identifier Type: -

Identifier Source: org_study_id

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