Autologous Muscle Derived Cells for Underactive Bladder

NCT02463448 | Completed Phase 1 Results DMC

• 1 other identifier: 2015-134
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, Phase 1, single center study evaluating the safety and efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.

Conditions

Urinary Retention; Urinary Incontinence

Keywords

Underactive Bladder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Study-related Adverse Events at 6 Months

  Safety of Autologous Muscle Derived Cells in the treatment of underactive bladder as measured by occurrences of study-related adverse events (AEs) reported by 6 months after enrollment. Number of reports of each adverse event is listed for events determined to be definitely or possibly related to study activities.

  6 months

Secondary Outcomes (10)

• Number of Participants With Study-related Adverse Events Between 6 and 12 Months

  Between 6 and 12 months

• Number of Participants With Improvement in Underactive Bladder Symptoms at 12 Months.

  12 months

• Number of Participants With Improvement in Underactive Bladder Symptoms at 12 Months.

  12 months

• Change in Incontinence Questionnaire (ICIQ) Long Form Score From Baseline at 12 Months.

  12 months

• Change in Underactive Bladder Questionnaire (UABQ) Score From Baseline at 12 Months

  12 months

Study Arms (1)

Autologous Muscle Derived Cells

EXPERIMENTAL

Autologous Muscle Derived Cells are obtained by needle biopsy from the subject's own thigh muscle. These cells are sent to a special lab for growth and processing. When ready the cells are sent to the treatment location for injection into the bladder wall.

Biological: Autologous Muscle Derived Cells

Interventions

Autologous Muscle Derived Cells BIOLOGICAL

A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall.

Autologous Muscle Derived Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, at least 18 years of age
• History of Underactive Bladder (UAB) for at least 6 months documented in the medical record
• Recurring UAB symptoms
• Subjects unresponsive to relief symptoms of UAB with previous use of medications and/or other treatments
• Voiding difficulty (complains of difficulty emptying the bladder)
• Post void residual greater than or equal to 150 mL
• Total UAB Questionnaire Score greater than or equal to 3
• Females of child-bearing potential agree to use a reliable form of birth control for the entire study duration
• Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires

You may not qualify if:

• Pregnant, plans to become pregnant or lactating
• History of bleeding diathesis, uncorrectable coagulopathy, or would refuse a blood transfusion
• Currently on anticoagulant therapy
• Obvious neurological impairment
• Simultaneously participating in another investigational drug or device study or use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
• Has been treated with an investigational device, drug, or procedure for UAB within the last 6 months.
• Medical condition or disorder that may limit life expectancy or that may cause protocol deviations (e.g. unable to perform self-evaluations and/or accurately report medical history, urinary symptoms, and/or data)
• History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months
• Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy
• History of radiation therapy to the bladder
• Tests positive for Hepatitis B (Hepatitis B Surface Antigen), and Anti-Hepatitis B Core Total Antibody, Hepatitis C (Anti-Hepatitis C virus enzyme immunoassay, Human Immunodeficiency Virus (HIV Type I and 2 Antibodies), and/or Syphilis
• Abnormal renal function
• An active urinary tract infection as evidenced by positive urine culture
• Taking medication(s) that affect urination (e.g. medically necessary, stable drugs) such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas
• Requires concomitant use of or treatment with immunosuppressive agents

Sponsors & Collaborators

• Jason Gilleran: lead

Study Sites (1)

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Retention; Urinary Incontinence; Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Results Point of Contact

• Title: Jennifer Giordano
• Organization: Beaumont Hospitals

jennifer.geiordano@beaumont.org

248-551-3517

Study Officials

• Jason Gilleran, MD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 4, 2015
• Study Start: November 16, 2016
• Primary Completion: December 1, 2019
• Study Completion: November 1, 2020
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)