Muscle Fiber Fragment Treatment for Urinary Incontinence

Recruiting in Palo Alto (17 mi)

Overseen by Gopal Badlani, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Wake Forest University

Must not be taking: Urination affecting drugs

Disqualifiers: Hypercontractile bladder, HIV, diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a patient's own muscle tissue to help control urine leakage by injecting it into the bladder area. It targets patients with weak bladder muscles that can't properly control urine flow, aiming to strengthen these muscles and improve urine control. Research has explored using muscle cells for reconstructing the lower urinary tract.

Will I have to stop taking my current medications?

Yes, if you are taking any medications that affect urination, including prescription drugs, over-the-counter drugs, or dietary supplements, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment for urinary incontinence?

Research shows that injecting autologous muscle-derived cells can effectively treat urinary incontinence, with studies reporting complete cure in many patients and improvements in others. This suggests that using muscle fiber fragments, which contain similar regenerative cells, could also be effective. ^{1 2 3 4 5}

Is the Muscle Fiber Fragment Treatment for Urinary Incontinence safe for humans?

Studies have shown that treatments using autologous muscle-derived cells, which are similar to muscle fiber fragments, have been evaluated for safety in humans for conditions like stress urinary incontinence and fecal incontinence. These studies generally report on the safety of the treatment over a 12-month period, suggesting it is safe for human use. ^{1 3 5 6 7}

How is the Muscle Fiber Fragment Treatment for Urinary Incontinence different from other treatments?

This treatment uses a patient's own muscle tissue, which is minced and injected to help regenerate muscle and improve urinary control, unlike other treatments that may use synthetic materials or donor tissues. It is a simpler and potentially more natural approach, as it involves using the body's own cells to repair and strengthen the affected area. ^{1 3 4 5 8}

Eligibility Criteria

This trial is for adult women aged 18-75 with urinary incontinence due to bladder neck or urethral issues. They must not be pregnant, breastfeeding, and should use birth control if sexually active. Participants need a bladder capacity over 100 ml and normal kidney function. Excluded are those with neurological disorders, muscle diseases, coagulation problems, significant pelvic organ prolapse, recent cellular therapy or investigational drug use.

Inclusion Criteria

My bladder can hold more than 100 ml of urine.

I am between 18 and 75 years old.

My kidney function is normal.

Exclusion Criteria

My bladder can hold less than 100 cc of urine.

I have a diagnosed bladder or kidney condition.

I am taking medication that affects how often I urinate.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a biopsy and receive a single injection of autologous muscle fiber fragments into the bladder neck sphincter region

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

5 visits (in-person) at 1 week, 6 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Autologous Muscle Fiber Fragments (Other)

Trial Overview The study tests the safety of autologous muscle fiber fragments as a treatment for urinary incontinence caused by sphincter insufficiency. It's aimed at helping those who have this condition due to either acquired (like stress incontinence) or congenital reasons.

Participant Groups

Group I: Autologous Muscle Fiber Fragments Experimental Treatment 1 Intervention

Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest Urology Clinic Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraurethral injection of autologous minced skeletal muscle: a simple surgical treatment for stress urinary incontinence. [2014] Intraurethral injection of in vitro expanded autologous skeletal muscle derived cells is a new regenerative therapy for stress urinary incontinence. We examined the efficacy and safety of a simpler alternative strategy using freshly harvested, minced autologous skeletal muscle tissue with its inherent content of regenerative cells.

2. Germany pubmed.ncbi.nlm.nih.gov

[Stem cell therapy for urinary incontinence]. [2018] Experimental and clinical studies investigated whether urinary incontinence can be effectively treated with transurethral ultrasound-guided injections of autologous myoblasts and fibroblasts.This new therapy was performed in eight female pigs. It could be shown that the injected cells survived well and that new muscle tissue was formed. Next, 42 patients (29 women, 13 men) suffering from urinary stress incontinence were treated. The fibroblasts were mixed with a small amount of collagen as carrier material and injected into the urethral submucosa to treat atrophies of the mucosa. The myoblasts were directly injected into the rhabdosphincter to reconstruct the muscle and to heal morphological and functional defects. In 35 patients urinary incontinence could be completely cured. In seven patients who had undergone multiple surgical procedures and radiotherapy urinary incontinence improved. No side effects or complications were encountered postoperatively. The experimental as well as the clinical data clearly demonstrate that urinary incontinence can be treated effectively with autologous stem cells. The present data support the conclusion that this new therapeutic concept may represent a very promising treatment modality in the future.

3. United States pubmed.ncbi.nlm.nih.gov

Skeletal Muscle-Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study. [2023] Fecal incontinence (FI) improvement following injection of autologous skeletal muscle-derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy.

4. United States pubmed.ncbi.nlm.nih.gov

Persistence and survival of autologous muscle derived cells versus bovine collagen as potential treatment of stress urinary incontinence. [2007] We explored the use of autologous muscle derived cells as a method of treating stress urinary incontinence. We determined whether urethral muscle derived cell injection is feasible and compared it with bovine collagen injection.

5. United States pubmed.ncbi.nlm.nih.gov

Transurethral autologous myoblast injection for treatment of urinary incontinence in children with classic bladder exstrophy. [2008] The application of autologous myoblasts is an area of active research that may represent an improved alternative for the treatment of urinary incontinence. In this study we investigated the effectiveness of autologous myoblast injection for the treatment of urinary incontinence in children with classic bladder exstrophy.

6. United States pubmed.ncbi.nlm.nih.gov

Autologous muscle derived cells for treatment of stress urinary incontinence in women. [2017] We assess the 12-month safety and potential efficacy of autologous muscle derived cells for urinary sphincter repair (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) in women with stress urinary incontinence.

7. United States pubmed.ncbi.nlm.nih.gov

Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study. [2022] In this feasibility study we assessed the 12-month safety and potential efficacy of autologous muscle derived cells (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) as therapy for stress urinary incontinence.

8. England pubmed.ncbi.nlm.nih.gov

Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. [2015] WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Cell therapy using muscle precursor cell (MPC) injections has shown promise for urinary incontinence due to intrinsic sphincter deficiency (ISD), but the cell-preparation process is complex and costly. Implantation of freshly isolated myofibres carrying MPCs, mainly satellite cells, was very efficient in repairing muscle damage in recent animal experiments. In a phase I clinical trial, we investigated whether periurethral myofibre implantation generated local myogenesis and improved continence in 10 patients (five men and five women) with ISD. We found that myofibre implantation increased intraurethral pressure and periurethral electromyographic activity in patients with ISD. There were no serious side-effects.