Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Temporarily halted
Participants planned
20
Countries
1
Sites
2
URethral stenosis
The main objective of this study is to assess the safety and tolerability of ADSVF, as add-on treatment to endoscopic urethrotomy for recurrent bulbar urethral stenosis during the follow-up.
Key facts
- Sponsor
- Centre Hospitalier Regional De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 13 Mar 2024 → ongoing
- Decision date (initial)
- 2024-07-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- DGOS
External identifiers
- EU CT number
- 2024-513306-65-00
- EudraCT number
- 2022-002175-11
- ClinicalTrials.gov
- NCT05857371
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The main objective of this study is to assess the safety and tolerability of ADSVF, as add-on treatment to endoscopic urethrotomy for recurrent
bulbar urethral stenosis during the follow-up.
Secondary objectives 2
- to obtain preliminary data on the efficacy of ADSVF injection as add-on treatment to endoscopic urethrotomy on: - validated symptoms scores (ICIQ male, USP and Personnal Global impression of Improvement (PGII scale), quantitative functional tests (uroflowmetry and post voiding residual assessment), recurrence rate (need for re intervention on the urethral stenosis) at 1, 3, 6, 9, 18 and 24 months, - imaging assessment of spongiofibrosis volume with Fat Sat sequences in an urethral MRI at 1 and 9 months
- Relationship of efficacy and safety results with imaging, ADSVF composition and biological characteristics will be explored.
Conditions and MedDRA coding
URethral stenosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Signed informed consent
- Male, aged from 18 to 85 years
- Bulbar urethral stenosis ≤ 3 cm Although there is no concensus on a clear definition of what a significant bulbar UrS is to date, a significant Bulbar UrS will be defined as 3 dimension entity for the study: - A narrowing of urethra that does not accept a standard flexible fibroscope (CH16) to pass through - In a patient with bothersome voiding and/or storage symptoms or any complication (infection, retention) who is asking for a relief - Qmax ≤ 15 ml/s AND USP ICIQ male LUTS voiding dysfunction domain ≠ 0 (Zero)
- At least one urethral dilatation or urthrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
- Ability to avoid corticoids or immunosuppressive drugs one month after treatment
- Good general health status according to clinical history and a physical examination
- BMI > 18 to insure adequate access to abdominal or other subcutaneous adipose tissue for adipose tissue harvesting
Exclusion criteria 13
- Urethral stenosis of other location than bulbar
- Urethral stenosis length > 3 cm
- Urethral stenosis on reconstructed penis (transgender, post amputation)
- Prior perineal or pelvic radiotherapy
- Concurent urinary tract infection without treatment
- Concurent perineal infection
- Penile cancer < 5 years
- Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease
- Congenital or acquired immunodeficiencies
- Contraindication to the anaesthetic or surgical procedure
- Corticoids or immunosuppressive drugs > 3 months
- Any active viral infection among the following: HIV, HTLV I and II, VHB, VHC and Syphillis
- Administrative restricted rights
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.
Secondary endpoints 4
- Symptoms and quality of life using validated scale and questionnaires: ICIQ male LUTS (International Consultation on incontinence Questionnaire), USP (Urinary Symptom Profile) questionnaires and a PGII (Personnal Global impression of Improvement) scale
- US examination: Uroflowmetry (Qmax in ml/s, voided volume in ml) and post voiding residual volume using ultrasound bladder scan.
- Recurrence occurring between 3 months and 24 months after the ADSVF injection and defined as a urinary retention or a decrease in uroflowmetry and quality of life equal to baseline situation ± 20% in a patient asking for a relief after an initial period of improvement (compare to baseline values)
- Volume of spongiofibrosis using MRI in Sagittal view in T1 Fat Sat after Gadolinium injection (reconstruction to evaluate total volume in mm3 of spongiofibrosis).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11403613 · Product
- Active substance
- Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 8 million organisms/ml million organisms/millilitre
- Max total dose
- 8 million organisms/ml million organisms/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- APHM
- Paediatric formulation
- No
- Orphan designation
- No
PRD11403668 · Product
- Active substance
- Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 8 million organisms/ml million organisms/millilitre
- Max total dose
- 8 million organisms/ml million organisms/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- APHM
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional De Marseille
- Sponsor organisation
- Centre Hospitalier Regional De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- INVESTIGATOR COORDINATOR
Public contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- project manager
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 20 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-03-13 | 2024-03-13 | 2026-03-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-124598
- Halt date
- 2026-03-23
- Planned restart
- 2026-09-01
- Member states concerned
- France
- Publication date
- 2026-03-23
- Reason
- Study management related, Sponsor decision
- Explanation
- The inclusion date has passed (2026-13-03). The sponsor is waiting for the DMC meeting on June 8th before making a substantial modification.
- Follow-up measures
- No modications
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2026-02-19
- Type
- 4
- Reason
- 7
- Immediate action required
- No
- Justification
- As part of its activities, the APHM sent an email 26/11/2025 to the ANSM to inform it of an unexpected change in the design of a critical medical device (MD): the diameter of one of the tubes in the PUREGRAFT bag, used for the initial collection of adipose tissue and for the first stages of manufacture. This modification, which could impact the quality of the sterile connection, required an immediate adaptation of the process.
This change affects six clinical trials:2024-516342-19-00 2024-513306-65-00,2024-517384-24-
00,2023-505149-20-00 2024-517794-24-00 et 2024-511858-44-00
In order to guarantee the quality and sterility of the product, a new transfer set has been introduced. This set, custom-made by Sartorius, is subjected to gamma irradiation to meet sterility requirements. From a quality management perspective, this change has been formally managed, incorporating all prior validations: documentary, aseptic, MPT, surgical use, leak testing, as well as the associated validation batches.
The IMPD will be gradually updated during 2026 to ensure the traceability and regulatory compliance of this change.
The sponsor is requested to submit immediately an MSA part I + II inclunding
- The applicant must provide a photo/diagram or detailed description of the new device (transfer set) and the contact time with the product.
- Proof of CE marking or the device's certificate of conformity must be provided.
- The documents available as mentioned in the initial email regarding prior validations of the device (documentary, aseptic, MPT, surgical use, watertightness, validation batches) must be provided.
- The complete change control report must be provided.
so that the ANSM can evaluate the change in sterile connection and allow it to continue to be included in this clinical trial
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2022-002175-11_PROTOCOLE _SURF | 2 |
| Recruitment arrangements (for publication) | 2024-513306-65-00 _recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | 2022-002175-11_ NIFC_SURF | 1.1 |
| Synopsis of the protocol (for publication) | 2022-002175-11_Resume_SURF | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-26 | France | Acceptable 2024-07-26
|
2024-07-26 |