Mode of action of the new treatment approach

What is being investigated in the study?

The objective of the study is to determine the efficacy and safety of a novel treatment for stress urinary incontinence in women – the administration of the body’s own muscle cells. In addition, the study aims to determine what amount of cells administered is sufficient to improve the symptoms of urinary incontinence.

How does the treatment approach work?

The therapy is carried out with the help of the patient’s own muscle cells.
For the production process, a piece of tissue is first removed from each patient’s own calf muscles. From this muscle tissue, the so-called “muscle precursor cells” are extracted and multiplied in a laboratory. As soon as a sufficiently large number of cells is available (about 4-5 weeks later), the muscle cells are injected into the sphincter of the urinary bladder.
There, fully functional muscle cells develop from these precursor cells, thereby promoting regeneration of the entire muscle. Since only the body’s own cells are used, acceptance by the body is very good.
The goal is to use this treatment method to strengthen the sphincter muscles and thus successfully treat stress incontinence with the body’s own muscle cells.

Has this treatment approach already been tested in previous studies?

The therapeutic approach has been tested for safety and efficacy in a wide variety of pre-clinical trials.
This new treatment method was tested in a phase I study conducted at the University Hospital Zurich and was completed without any serious or unexpected side effects.

Procedure of the study

Where will the study be conducted?

All visits will take place at the University Hospital of Zurich.

How long and how often do I have to participate?

The study lasts approximately 8-9 months per patient and includes 7-8 study visits. All visits take place at the University Hospital Zurich.

When does the study start? Is there a waiting period?

The study is planned to start in the second half of 2022.

Due to capacity constraints, it may take some time before you can actually start the study. You can find out the expected current waiting period from the study information service or the study coordinator. There should be a maximum of 3 months between the so-called screening, where the investigator checks on site whether you are suitable for the study, and the actual start of the study for you.

Do I have to come to Zurich?

Yes, this is necessary because the study is only conducted there. Thus, the follow-up examinations, which are necessary for the collection of the relevant data, must take place there.

How long do the treatment and follow-up examinations last?

The treatment and follow-up examinations last approximately half a year. The first consultation is about 12 weeks before the muscle biopsy is taken. After the injection of the cells has been completed, the main follow-up appointments take place after 1, 3 and 6 months respectively.

Do I have to be admitted as an inpatient?

For the injection of the cells, a hospital stay of one day (or longer in case of medical complaints) might be necessary for control purposes. This decision is made by the attending physician at the University Hospital.

How are the surgeries performed? Do scars remain?

For the muscle biopsy on the lower leg, a small skin incision of 2 – 4 cm length is needed. The wound is sutured closed and a small scar remains from the corresponding skin incision. The injection of the muscle cells is ultrasound-guided through the urethra and is not visible from the outside.

Is it correct that two procedures with anesthesia are necessary for the treatment?

Correct. Anesthesia will be necessary for the removal and implantation of the muscle cells. The type of anesthesia in each case will be discussed with the attending physician prior to the procedure.

Why are the two procedures not performed in the same session (i.e. on the same day)?

After taking the muscle biopsy and isolating the precursor cells, they must first be grown in the laboratory under highly sterile conditions. The average growth time is about 4-5 weeks until a sufficient number of muscle cells can be grown.

Are only autologous cells transplanted?

Yes, from the muscle biopsy of the lower leg, muscle precursor cells are isolated in the laboratory and then multiplied. After reaching a certain number, these autologous cells are injected into the bladder sphincter.

Participation options

For whom is the study eligible?

Patients can participate in the study if they

  • are female
  • are between 18 and 65 years old
  • have been suffering from stress incontinence for at least 6 months
  • have had at least one conservative treatment option (e.g. physiotherapy) that has not been successful
  • and who have not yet undergone surgery for their incontinence.

In addition, there are further inclusion and exclusion criteria which must be checked by the study center before participation. In a first step, patients have the possibility to perform a non-binding preliminary check of some criteria. In case of any further open questions, there is also the possibility to contact (anonymously if desired) our study information service. However, the decisive medical examination (i.e. screening) on this question takes place exclusively at the University Hospital Zurich itself.

How do I find out whether I can participate in the study?

With our questionnaire, you can easily and without obligation check whether you are essentially eligible for the study.

Can I participate in the study even if I am currently being treated with another method?

Your study doctor will also discuss with you the possibility of treatment outside of this study. Other treatments include surgery or medication. These options are still available to you after you have participated in our study.
Please discuss with the study physician whether a therapy that has already been started can be continued.

Opportunities and risks of participating in the study

Is it possible that I will receive a placebo treatment in the study?

No, all patients are treated with the same real therapy, namely with the body’s own muscle cells.
Only the dose of the injected solution varies.

Will I be cured of my incontinence after the procedure?

That is desirable, of course! However, this question is the subject of the study investigation and cannot be answered today.

What are the possible chances of the treatment option?

The objective is to investigate whether the therapy is effective and whether symptoms of bladder incontinence can be cured or alleviated. However, in clinical trials it is not certain whether you yourself will have any personal benefit at all from participating in this trial, because the therapy may not show any efficacy at all.
No serious or unexpected side effects were observed in a previously conducted phase 1 clinical trial with 9 patients.
In any case, your participation will contribute to a better understanding of the treatment of this disease and thus benefit patients suffering from the same disease in the future.

Are the procedures painful? What complications are possible or to be expected?

Generally, both are minor surgical procedures with low complication rates. Mild to moderate pain (comparable to severe muscle soreness or strain) may occur after muscle biopsy of the lower leg. Wound infections and/or bruising are among the possible complications. Subsequent burning during urination is likely after cell injection. Bladder infection and/or urinary retention (inability to urinate voluntarily) are among the possible complications. However, all side effects can be well treated and resolved.

Cost of the procedure

What are the costs?

All study-specific examinations and treatments or study medications are free of charge. Neither you nor your health insurance company will incur any additional costs in connection with your participation.
You will be reimbursed for reasonable travel costs incurred for your visits until the treatment phase according to the guidelines of the University Hospital Zurich.

Is there any compensation for participation?

No, you will not receive any financial compensation for participating in this clinical trial.

Further information and contact

Can I talk to my doctors about participation?

Yes, we will be happy to send you information to discuss with your treating physician. You can find the contact details of the study information service here: Study Information Service. At the study center, you can discuss all questions regarding study participation with the study physician.

Will my doctors be kept informed about my participation in the study program and its results?

If you wish, your primary care physician will be informed about your participation in the study. Please ask the study team at the University Hospital about this.

Can I withdraw my consent to participate or end my participation early?

Yes, because your participation in this study is voluntary. If you withdraw your consent, once you have given it, at a later date, you will not have to worry about any disadvantages to your medical care. You have this option to end your participation at any time.

If you revoke your consent after a biopsy or injection has been performed, you will be examined again for your safety at the termination of your participation in the study (“end of study” visit).

How can I contact you? / Who can I contact if I still have questions about the study?

You can use the online questionnaire to check easily, anonymously and without obligation whether you are suitable for study participation. However, the decisive medical examination (screening) on this question takes place exclusively at the University Hospital Zurich itself.

If you have any questions, you can contact the study information service or the study coordinator. You can reach our study information service by e-mail at muvon-studieninfo@admedicum.com or by phone at +41 435083668 (Switzerland) or at +49 2236 3189645 (Germany).

Who is MUVON Therapeutics AG?

MUVON Therapeutics AG is a spin-off of the University of Zurich. MUVON aims to promote personalized cell therapy for the regeneration of skeletal muscle tissue. The first focus is to develop a safe and effective treatment for stress urinary incontinence in women to support them on their way to a healthy life.

Website MUVON Therapeutics AG