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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Lyon Sud	Pierre Benite	France
Augodbpeym Pacplpfx Huwichmx Dq Mbivunjcq	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	13.03.2024

Trial locations

Investigated drugs:

Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells

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.

Investigated diseases:

Urethral stenosis

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 ID:

2024-513306-65-00

Protocol code:

SURF

NCT ID:

NCT05857371

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?