Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
36
Countries
1
Sites
2
SCARRED VOCAL FOLDS
Evaluate and compare the efficacy of fresh autologous adipose-derived stromal vascular fraction injection, in comparison with a placebo (saline solution and human serum albumin, vehicle of SVF without cells), on dysphonia linked to scarred vocal cords, based on a self-assessment via the Voice Handicap Index (significan…
Key facts
- Sponsor
- Centre Hospitalier Regional De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- 22 Sep 2022 → ongoing
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517384-24-00
- EudraCT number
- 2020-004227-17
- ClinicalTrials.gov
- NCT05385159
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Evaluate and compare the efficacy of fresh autologous adipose-derived stromal vascular fraction injection, in comparison with a placebo (saline solution and human serum albumin, vehicle of SVF without cells), on dysphonia linked to scarred vocal cords, based on a self-assessment via the Voice Handicap Index (significant improvement if ≥ 18 points according to Jacobson) at 6 months post treatment.
Secondary objectives 3
- To evaluate the safety of the injection of stromal vascular fraction (fresh or after thawing) as well as its feasibility which will be judged on per-operative and post-operative criteria
- To evaluate and compare the efficacy at 1 month and 6 months of the fresh ADSVF injection in comparison with placebo, on the following criteria
- Identify patients who will clinically respond to SVF local administration using in vitro experiments
Conditions and MedDRA coding
SCARRED VOCAL FOLDS
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Subscription to the French Social Security System
- Voice Handicap Index > 50/120
- Scarred vocal folds, congenital (sulcus) or after phonosurgery
- Scarred middle third in videolaryngostroboscopy
- At least six-months delay after initial surgery if appropriate
- Patients aged between 18 and 70
- Good general condition
- Negative pregnancy test & contraception for women of child-bearing age
Exclusion criteria 10
- Refusal of speech therapy
- History of malignant lesion or severe dysplasia of the scarred vocal fold
- History of laryngeal papillomatosis
- Contre-indication à l'anesthésie locale
- Anti-coagulant treatment
- Coagulation disorders (Prothrombin Ratio <65%, Activated Partial Thromboplastin Time >1,2)
- Active infectious diseases
- Any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis
- Known sensitivity to human serum albumin (HSA)
- BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)
Secondary endpoints 7
- VHI at 1 month
- self-evaluation of dysphonia (0-10 scale)
- voice acoustic measurements
- voice aerodynamic measurements: maximum phonation time
- perceptive analysis (GRB scale): score will be calculated by addition of two characteristics
- videolaryngostroboscopy
- The incidence of related Adverse Events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11404593 · Product
- Active substance
- Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 10 million organisms million organisms
- Max total dose
- 10 million organisms million organisms
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- APHM
- Paediatric formulation
- No
- Orphan designation
- No
PRD11403730 · Product
- Active substance
- Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- APHM
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
PRD11328072 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- 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
- Alexia Mattei
Public contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Alexia Mattei
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 36 | 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 | 2022-09-22 | 2022-09-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
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 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517384-24-00 | 7.1 |
| Protocol (for publication) | D1_Protocol_TC_2024-517384-24-00 | 7.1 |
| Protocol (for publication) | D2_PROTOCOL MODIFICATION_2024-517384-24-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC_2024-517384-24-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of the protocol_2024-517384-24-00 | 6.1 |
| Synopsis of the protocol (for publication) | D1_Synopsis of the protocol_TC_2024-517384-24-00 | 6.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-29 | France | Acceptable 2024-09-24
|
2024-09-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-05 | France | Acceptable 2026-02-24
|
2026-03-12 |