DysphoniaNCT02622464
Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
A study testing micro injection of SVF in vocal cords in people with Dysphonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphonia
- What is being tested?
- micro injection of SVF in vocal cords
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2016to 7 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vocal Difficulties felt as crippling (VHI > 60/120)
- Presence of scar hurts of the caused vocal cords is by the initial surgery (micro-laryngoscopy in suspension with or without laser) or by a congenital pathology of glottidis sulcus
- Scar Aspect of vocal cords judged on a stroboscopic examination
- Delay of at least 1 year with regard to the initial surgery
Who cannot join
- Patients refusing the speech therapy
- Patients operated for a malignant lesion or in malignant potential serious dysplasia of the scar vocal cord
- Contraindication in the anesthesia
- Patients under anti-coagulants
- Patients presenting disorders of the coagulation
- Active infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. There is no currently codified treatment for this type of situation and no therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population including multipotent stem cells similar to mesenchymal stem cells present in bone marrow. The investigators hypothesis is that the trophic and antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible for dysphonia.
- Conditions
- Dysphonia
- Being tested
- micro injection of SVF in vocal cords
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro injection of SVF in vocal cordsOther
| Study group | Role | What they receive |
|---|---|---|
| micro injection of SVF in vocal cords | Experimental | micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords Receives: Other: micro injection of SVF in vocal cords |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of Stromal Vascular Fraction injection injected in vocal cords
feasibility will be assessed by observation of the immediate volumizing effect on the edge free of the vocal cord appreciated on the video document
Measured: 13 months
safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords
safety of Stromal Vascular Fraction injection injected in vocal cords
Measured: 13 months
Secondary outcomes (2)
efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
efficiency of SVF injection will be assessed by visual analysis of the vocal cord vibration appreciated by vidéolaryngostroboscopy
Measured: 13 months
efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start7 Apr 2016
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine GIOVANNI, MD, Principal investigator, assistance publique hôpitaux de marseillecatherine GEINDRE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622464
- Sponsor's protocol ID
- 2015-01
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2015
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mattei A, Bertrand B, Jouve E, Blaise T, Philandrianos C, Grimaud F, Giraudo L, Aboudou H, Dumoulin C, Arnaud L, Revis J, Galant C, Velier M, Veran J, Dignat-George F, Dessi P, Sabatier F, Magalon J, Giovanni A. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Apr 1;146(4):355-363. doi: 10.1001/jamaoto.2019.4328.
PubMed 32053141
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
- ClinicalTrials.gov ID
- NCT02622464
- Acronym / sponsor ID
- 2015-01
- Conditions
- Dysphonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. There is no currently codified treatment for this type of situation and no therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population including multipotent stem cells similar to mesenchymal stem cells present in bone marrow. The investigators hypothesis is that the trophic and antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible for dysphonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro injection of SVF in vocal cords | Experimental | Other: micro injection of SVF in vocal cordsmicro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Vocal Difficulties felt as crippling (VHI > 60/120)
- Presence of scar hurts of the caused vocal cords is by the initial surgery (micro-laryngoscopy in suspension with or without laser) or by a congenital pathology of glottidis sulcus
- Scar Aspect of vocal cords judged on a stroboscopic examination
- Delay of at least 1 year with regard to the initial surgery
Key exclusion criteria (6 listed)
- Patients refusing the speech therapy
- Patients operated for a malignant lesion or in malignant potential serious dysplasia of the scar vocal cord
- Contraindication in the anesthesia
- Patients under anti-coagulants
- Patients presenting disorders of the coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro injection of SVF in vocal cords | Other | micro injection of SVF in vocal cords |
Primary outcome
feasibility of Stromal Vascular Fraction injection injected in vocal cords
Time frame: 13 months
feasibility will be assessed by observation of the immediate volumizing effect on the edge free of the vocal cord appreciated on the video document
safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords
Time frame: 13 months
safety of Stromal Vascular Fraction injection injected in vocal cords
2 secondary outcomes
efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
Time frame: 13 months
efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 32053141Mattei A, Bertrand B, Jouve E, Blaise T, Philandrianos C, Grimaud F, Giraudo L, Aboudou H, Dumoulin C, Arnaud L, Revis J, Galant C, Velier M, Veran J, Dignat-George F, Dessi P, Sabatier F, Magalon J, Giovanni A. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Apr 1;146(4):355-363. doi: 10.1001/jamaoto.2019.4328.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine GIOVANNI, MD principal investigator
assistance publique hôpitaux de marseille
catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro injection of SVF in vocal cords in people with Dysphonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of Stromal Vascular Fraction injection injected in vocal cords (time frame: 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.