Trial Outcomes & Findings for Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use (NCT NCT01648491)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2017-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Stem Cell Treatment Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stem Cell Treatment n=1 Participants Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Stem Cell Treatment n=1 Participants Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Study-Related Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: Baseline and 6 months

The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible.

Outcome measures

Outcome measures
Measure	Stem Cell Treatment n=1 Participants Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire Question 1: Baseline Score	4 units on a scale
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire Question 1: 6 Months Post-Injection Score	4 units on a scale
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire Question 2: Baseline Score	5 units on a scale
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire Question 2: 6 Months Post-Injection Score	6 units on a scale

SECONDARY outcome

Timeframe: 6 months

The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.

Outcome measures

Outcome measures
Measure	Stem Cell Treatment n=1 Participants Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)	4 units on a scale

SECONDARY outcome

Timeframe: 6 months

The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.

Outcome measures

Outcome measures
Measure	Stem Cell Treatment n=1 Participants Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)	4 units on a scale

Adverse Events

Stem Cell Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth Peters MD

Beaumont Hospital - Royal Oak

Phone: 248-551-0387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place