96 Participants Needed

Cell-Based Therapy for Stress Urinary Incontinence

(CELLEBRATE Trial)

Recruiting at 22 trial locations
KD
KD
CS
MJ
EM
Overseen ByErvin Mazniku, M.D., M.Sc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for women who still have urine leakage after surgery. The treatment uses their own muscle cells, which are injected into the urinary passage to help strengthen it. The goal is to reduce accidental urine leakage during activities like laughing or coughing. Muscle-derived cells have been previously used in treatments for urinary incontinence, showing promise in improving urethral closure and reducing symptoms.

Do I have to stop taking my current medications for the trial?

You may need to stop or adjust your current medications if they affect lower urinary tract function. If you are taking such medications, you must be on a stable dose for at least 2 weeks before the trial and maintain it during the study.

Will I have to stop taking my current medications?

The trial requires that if you are taking medications that affect urinary function, like certain antidepressants or diuretics, you must be on a stable dose for at least 2 weeks before screening and throughout the study. If you can't maintain a stable dose, you may need to stop or adjust your medication.

What safety data is available for cell-based therapy for stress urinary incontinence?

The safety data for cell-based therapy, specifically autologous muscle-derived cells (AMDC), for stress urinary incontinence indicates that the treatment is generally safe. Multiple studies, including double-blind, randomized, placebo-controlled trials, have been conducted to assess the safety and efficacy of AMDC. These studies report no serious procedure or treatment-related adverse events. In trials for underactive bladder, which also used AMDC, no study-related adverse events or side effects were reported, and the treatment was described as safe and minimally invasive. Overall, the existing safety data suggests that AMDC therapy is a promising and safe treatment option for urinary incontinence.12345

Is cell-based therapy for stress urinary incontinence safe?

Research on autologous muscle-derived cells (AMDC) for urinary conditions, including stress urinary incontinence and underactive bladder, shows that these treatments are generally safe, with no serious adverse events reported in clinical trials.12345

Is the treatment AMDC-USR (iltamiocel) a promising treatment for stress urinary incontinence?

Yes, AMDC-USR (iltamiocel) is a promising treatment for stress urinary incontinence. Studies show it can help repair the urinary sphincter muscle, reduce incontinence episodes, and improve muscle function. This cell-based therapy offers hope for those who haven't found success with other treatments.12367

How is the treatment AMDC-USR (iltamiocel) different from other treatments for stress urinary incontinence?

AMDC-USR (iltamiocel) is unique because it uses autologous muscle-derived cells, which are cells taken from the patient's own muscle, to repair the urinary sphincter. This cell-based therapy aims to regenerate the sphincter muscle, offering a novel approach compared to traditional treatments like physical exercises or medications.12367

What data supports the idea that Cell-Based Therapy for Stress Urinary Incontinence is an effective treatment?

The available research shows that Cell-Based Therapy for Stress Urinary Incontinence, specifically using autologous muscle-derived cells, is effective. One study found that these cells helped repair the urinary sphincter in women with stress urinary incontinence. Another study showed that injections of these cells reduced the frequency of stress incontinence episodes. Additionally, in animal studies, this therapy improved the function of the urethral sphincter, which is important for controlling urination. Compared to other treatments, this cell-based approach directly targets the muscles involved in urinary control, potentially offering a more direct and effective solution.12689

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

Research shows that autologous muscle-derived cells (AMDC) can help repair the urinary sphincter, reducing stress urinary incontinence episodes. Studies also indicate that similar cell-based therapies have improved muscle function in both animal models and human trials, suggesting potential benefits for this condition.12689

Who Is on the Research Team?

MK

Melissa Kaufman, M.D., Ph.D.

Principal Investigator

Vanderbilt University Medical Center, Department of Urologic Surgery

Are You a Good Fit for This Trial?

This trial is for adult women over 18 who have moderate-to-severe stress urinary incontinence despite having surgery for it. They must not be pregnant, planning pregnancy, or breastfeeding, and should not have a BMI of 35 or higher. Participants need to have tried other treatments like pelvic exercises and cannot be on certain medications affecting the bladder.

Inclusion Criteria

I am a woman over 18 with severe bladder control issues for 6+ months.
Must have completed 100% of the screening 3-day diary evening reports
I have had surgery for stress urinary incontinence before.
See 1 more

Exclusion Criteria

My BMI is 35 or higher.
I mainly experience sudden urges to urinate that I cannot control.
I have experienced stress urinary incontinence for less than 6 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of either AMDC-USR or placebo for urinary sphincter repair

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants who received placebo may opt to receive an injection with their cells after the blinded portion

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • AMDC-USR (iltamiocel)
  • Placebo
Trial Overview The study tests Autologous Muscle Derived Cells (AMDC-USR) against a placebo in reducing stress incontinence episodes. Women will randomly receive either cell injections or a placebo to see which is more effective at treating their condition after previous surgeries failed.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AMDC-USR (iltamiocel)Experimental Treatment1 Intervention
Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.
Group II: PlaceboPlacebo Group1 Intervention
Placebo control is the vehicle solution used for the study product.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cook MyoSite

Lead Sponsor

Trials
14
Recruited
1,100+

Published Research Related to This Trial

The study found that autologous muscle-derived cells for urinary sphincter repair (AMDC-USR) were safe and well-tolerated, with no serious adverse events reported among female subjects with stress urinary incontinence.
Although the primary efficacy results were inconclusive due to a high placebo response rate (90%), post hoc analyses indicated that stricter endpoints might reveal a potential treatment effect, suggesting the need for refined trial designs in future studies.
A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence.Jankowski, RJ., Tu, LM., Carlson, C., et al.[2021]
In a study of 58 participants, both autologous muscle-derived cell (AMDC) injections and placebo injections led to significant increases in urethral sphincter volumes and reductions in stress incontinence episode frequency (IEF) after 12 months, but there were no significant differences between the two groups.
Factors such as longer urethral length and larger external sphincter volume at baseline were associated with better responses to AMDC injections, suggesting these may be important predictors of treatment efficacy.
Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.Ismail, S., Morin, M., Tu, LM.[2021]
Skeletal muscle-derived mononuclear cells (SMDMCs) were successfully incorporated into the urethra of female rats, promoting recovery of the damaged urethral sphincter after stress urinary incontinence surgery.
The SMDMC treatment led to a significant reduction in connective tissue deposition and an increase in muscle content compared to the saline control group, indicating potential efficacy for this novel cell-based therapy.
Periurethral muscle-derived mononuclear cell injection improves urethral sphincter restoration in rats.Turco, MP., de Souza, AB., de Campos Sousa, I., et al.[2018]

Citations

A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence. [2021]
Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound. [2021]
Periurethral muscle-derived mononuclear cell injection improves urethral sphincter restoration in rats. [2018]
Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study. [2023]
Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. [2015]
Regenerative medicine- techniques and methods of administering autologous derived stem cells in urinary incontinence. [2018]
Improved global response outcome after intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder. [2021]
Intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder: pilot study. [2018]
Towards a Treatment of Stress Urinary Incontinence: Application of Mesenchymal Stromal Cells for Regeneration of the Sphincter Muscle. [2020]
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