Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on the Safety of Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells for Patients with Recurrent Urethral Stricture

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the condition known as urethral stricture, which is a narrowing of the urethra that can cause problems with urination. The study is investigating a new treatment approach that involves the use of stromal vascular fraction cells derived from a patient's own fat tissue. These cells are injected as an additional treatment alongside a procedure called endoscopic urethrotomy, which is a surgical method used to treat the narrowing of the urethra.

The purpose of the study is to evaluate the safety and potential benefits of this innovative treatment. Participants in the study will receive either the new cell-based treatment or a placebo, in addition to the standard surgical procedure. The treatment involves injecting the cells under the skin, and the study will monitor participants over a period of time to assess any side effects and improvements in symptoms.

Throughout the study, participants will undergo various assessments, including questionnaires about their symptoms and quality of life, as well as tests like uroflowmetry to measure urine flow and MRI scans to evaluate changes in the urethra. The study aims to provide valuable information on whether this new treatment can help improve outcomes for patients with urethral stricture.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide a signed informed consent.

    Eligibility criteria include being male, aged 18 to 85 years, with a specific type of urethral narrowing (bulbar urethral stenosis) that is 3 cm or less in length.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure good general health status through clinical history and a physical examination.

    The patient must have a body mass index (BMI) greater than 18 to ensure adequate access to adipose tissue for harvesting.

  3. Step 3

    Treatment preparation

    The treatment involves the use of autologous adipose tissue-derived stromal vascular fraction cells.

    These cells are prepared as a suspension for injection.

  4. Step 4

    Treatment administration

    The prepared cell suspension is administered through a subcutaneous injection.

    This is an additional treatment to the standard endoscopic procedure for urethral narrowing.

  5. Step 5

    Follow-up and monitoring

    The main objective is to assess the safety and tolerability of the treatment during follow-up.

    Safety endpoints include monitoring for adverse events such as urethral bleeding, urinary infection, and urethral pain.

  6. Step 6

    Evaluation of treatment effects

    The effects of the treatment on symptoms and quality of life will be evaluated using questionnaires and scales.

    Additional assessments include uroflowmetry and ultrasound bladder scans to measure urine flow and residual volume.

  7. Step 7

    Long-term follow-up

    The study will monitor for recurrence of symptoms between 3 months and 24 months after the injection.

    MRI scans may be used to evaluate changes in the tissue structure.

Who can join the trial?

7 criteria

  • You must sign a document called an informed consent, which means you agree to participate in the study after understanding what it involves.
  • You need to be a male between the ages of 18 and 85 years old.
  • You should have a condition called bulbar urethral stenosis, which is a narrowing of a part of the urethra. It should be 3 cm or less in length. This means the urethra is too narrow for a standard medical tool to pass through, and you have symptoms that bother you or cause complications like infections or difficulty urinating.
  • You must have had at least one procedure called urethral dilatation or urethrotomy for this condition in the past 24 months.
  • You should be able to avoid taking medications called corticoids or immunosuppressive drugs for one month after the treatment. These are medicines that affect your immune system.
  • You need to be in good general health based on your medical history and a physical check-up.
  • Your Body Mass Index (BMI) should be more than 18. This is a measure of body fat based on your height and weight, and it ensures there is enough fat tissue for a procedure involved in the study.

Who cannot join the trial?

4 criteria

  • Only male participants are allowed, so females cannot participate.
  • Participants must be within a specific age range, so those outside this range cannot join.
  • Individuals with conditions other than urethral stenosis may not be eligible. Urethral stenosis is a condition where the tube that carries urine out of the body is narrowed.
  • Participants must not belong to a vulnerable population, which means they should not be in a group that needs special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ADSVF: This is an innovative treatment that involves using a special type of cells called stromal vascular fraction, which are taken from the patient's own fat tissue. These cells are injected as an additional treatment to help with the healing process after a procedure called endoscopic urethrotomy, which is used to treat a condition known as urethral stenosis. The goal of using ADSVF is to see if it can improve the safety and effectiveness of the standard treatment for this condition.

What is already known about the treatment

Stromal Vascular Fraction (SVF) – This medication is administered through an injection and is being studied as an innovative treatment for urethral stenosis. Currently, it is in clinical trials to evaluate its safety and effectiveness when used alongside endoscopic urethrotomy. The main therapeutic indication is for recurrent bulbar urethral stenosis. At the molecular level, SVF is believed to aid tissue repair and regeneration by providing a rich source of stem cells and growth factors. It is classified under regenerative medicine therapies.

Investigated diseases

Urethral Stenosis – Urethral stenosis is a condition characterized by the narrowing of the urethra, which is the tube that carries urine from the bladder out of the body. This narrowing can lead to difficulty in urination, causing symptoms such as a weak urine stream, straining to urinate, and incomplete bladder emptying. Over time, the condition may result in increased urinary frequency and urgency, as well as urinary tract infections due to the obstruction. The progression of urethral stenosis can vary, with some individuals experiencing gradual worsening of symptoms. In some cases, the condition may lead to urinary retention, where the bladder cannot be fully emptied. The severity and impact of the condition can differ based on the degree of narrowing and the location within the urethra.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513306-65-00Protocol codeSURFEstimated enrolment20 patientsSponsorCentre Hospitalier Regional De Marseille

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.