Autologous Muscle Derived Cells for Underactive Bladder

NCT ID: NCT02463448

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-16
• Study Completion Date: 2020-11-30

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.

Detailed Description

Subject that meet inclusion and exclusion criteria will be consented and enrolled in this study. Initial screening includes blood and urine testing, questionnaires, physical examination, specialized bladder function testing and review of medical history. At the next visit a small sample of each subject's own thigh muscle is obtained by needle biopsy. This cell biopsy is sent to a specialized lab for growth and processing. Approximately ten weeks later the frozen cells will be sent back to the treatment site for thawing, diluting and injection under lighted instrumentation into the subject's bladder wall. The subject will be followed for 6 months and at that time may be eligible for a second injection of cells. The study doctor will determine if the second injection may be beneficial to the subject. All subjects will be followed for up to 12 months. The follow-up assessments at 12 months will include questionnaires, urine and blood testing, specialized bladder function testing and visualizing the inside of the bladder with a lighted instrument.

Conditions

Urinary Retention; Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Muscle Derived Cells

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.

Group Type: EXPERIMENTAL

Autologous Muscle Derived Cells

Intervention Type: 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.

Interventions

Autologous Muscle Derived Cells

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Males and females, at least 18 years of age

2. History of Underactive Bladder (UAB) for at least 6 months documented in the medical record

3. Recurring UAB symptoms

4. Subjects unresponsive to relief symptoms of UAB with previous use of medications and/or other treatments

5. Voiding difficulty (complains of difficulty emptying the bladder)

6. Post void residual greater than or equal to 150 mL

7. Total UAB Questionnaire Score greater than or equal to 3

8. Females of child-bearing potential agree to use a reliable form of birth control for the entire study duration

9. Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires

Exclusion Criteria

1. Pregnant, plans to become pregnant or lactating

2. History of bleeding diathesis, uncorrectable coagulopathy, or would refuse a blood transfusion

3. Currently on anticoagulant therapy

4. Obvious neurological impairment

5. Known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, ampicillin, and/or lidocaine that medically warrants exclusion as determined by the physician

6. 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

7. Has been treated with an investigational device, drug, or procedure for UAB within the last 6 months.

8. 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)

9. History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months

10. Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy

11. History of radiation therapy to the bladder

12. 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

13. Abnormal renal function

14. An active urinary tract infection as evidenced by positive urine culture

15. 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

16. Requires concomitant use of or treatment with immunosuppressive agents

17. Pelvic organ prolapse beyond the introitus (e.g., cystocele, rectocele)

18. Abnormal bladder capacity (i.e., less than 100 mL)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jason Gilleran

OTHER

Sponsor Role: lead

Responsible Party

Jason Gilleran

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jason Gilleran, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Health

Locations

Beaumont Health

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-134

Identifier Type: -

Identifier Source: org_study_id