Improved Healing of Scarred Vocal FoldsPhase 1NCT01981330
Pilot Study of Stem Cell Treatment of Patients With Vocal Fold Scarring
A Phase 1 study testing aMSC and aMSC+hyaluronan gel in people with Improved Healing of Scarred Vocal Folds and Improved Vocal Fold Status, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or possibly hereditary). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Improved Healing of Scarred Vocal Folds, Improved Vocal Fold Status, Improved Vocal Fold Function
- What is being tested?
- aMSC and aMSC+hyaluronan gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to 24 Feb 2020
- Phase
- Phase 1
- 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
- severe hoarseness
- vocal fold scarring
- no active other treatment
- age above 18 years
Who cannot join
- active treatment of laryngeal disorder
- active inflammatory condition of the larynx
- diagnosed or suspicions of local malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel
This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or possibly hereditary). The patients are operated with phonomicrosurgical dissection of the scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma cells, aMSC (which were previously harvested from each patients´s bone marrow, purified, expanded and characterized according to standard procedure at the Center of Hematology and Regenerative Medicine Karolinska University Hospital Huddinge). 8 Patients is planned to be treated with a single injection of aMSC and 8 patients with injection of aMSC mixed with a carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska Institute. The laryngeal status, vocal fold function, and voice function will be followed individually with an advanced battery of examinations performed before and up to 1 year postoperatively. Side effects and complications are noted and reported during surgery and following surgery at regular intervals during at least 1 year Since spring 2015 no new patients have been recruited and no treatments are given during 2016 or 2017. The monitoring authority was changed from Swedish National Board of Health to Swedish Medical Product Agency (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission is granted from MPA to continue the study.
- Conditions
- Improved Healing of Scarred Vocal Folds, Improved Vocal Fold Status, Improved Vocal Fold Function
- Being tested
- aMSC, aMSC+hyaluronan gel
- Keywords
- vocal fold scarring, mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aMSCBiological
aMSC injected into the vocal fold of the patient
aMSC+hyaluronan gelBiological
aMSC+ hyaluronan gel is injected into the patients vocal fold
| Study group | Role | What they receive |
|---|---|---|
| aMSC with and without hyaluronan gel | Experimental | autologous mesenchymal stem cells (aMSC) injected into the vocal folds in 8 patients and aMSC mixed with hyaluronan gel in 8 patients Receives: Biological: aMSC; Biological: aMSC+hyaluronan gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved healing of scarred vocal folds
Laryngeal and general ear, nose, and throat status will be followed for each patient at least one year after primary treatment. This includes examination of signs of local (laryngeal) inflammatory reaction/defect healing, e.g. polyp or granuloma formation, inflammatory reaction after local aMSC injection It also includes repetitive examinations of vocal fold function and voice function including high speed examination of the vocal folds, acoustic voice analysis and phonation pressure measurements as well as subjective ratings by means of Voice handicap index scale
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2012
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
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 Improved Healing of Scarred Vocal FoldsStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Laryngfonden, Karolinska Institutet
- Responsible party
- Principal investigator, Stellan Hertegård, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981330
- Sponsor's protocol ID
- 2010/1650 and 2014-51432
- Status last verified
- Feb 2020
- First submitted
- 5 Nov 2013
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hertegard S, Nagubothu SR, Malmstrom E, LeBlanc K. Treatment of vocal fold scarring with autologous bone marrow-derived human mesenchymal stromal cells-first phase I/II human clinical study. Stem Cell Res Ther. 2020 Mar 20;11(1):128. doi: 10.1186/s13287-020-01632-8.
PubMed 32197630
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel
- ClinicalTrials.gov ID
- NCT01981330
- Acronym / sponsor ID
- 2010/1650 and 2014-51432
- Conditions
- Improved Healing of Scarred Vocal Folds, Improved Vocal Fold Status, Improved Vocal Fold Function
- Keywords
- vocal fold scarring, mesenchymal stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Laryngfonden, Karolinska Institutet
- Study start
- Jan 2012
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 11 Nov 2013 (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.
This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or possibly hereditary). The patients are operated with phonomicrosurgical dissection of the scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma cells, aMSC (which were previously harvested from each patients´s bone marrow, purified, expanded and characterized according to standard procedure at the Center of Hematology and Regenerative Medicine Karolinska University Hospital Huddinge). 8 Patients is planned to be treated with a single injection of aMSC and 8 patients with injection of aMSC mixed with a carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska Institute. The laryngeal status, vocal fold function, and voice function will be followed individually with an advanced battery of examinations performed before and up to 1 year postoperatively. Side effects and complications are noted and reported during surgery and following surgery at regular intervals during at least 1 year Since spring 2015 no new patients have been recruited and no treatments are given during 2016 or 2017. The monitoring authority was changed from Swedish National Board of Health to Swedish Medical Product Agency (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission is granted from MPA to continue the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aMSC with and without hyaluronan gel | Experimental | Biological: aMSC, Biological: aMSC+hyaluronan gelautologous mesenchymal stem cells (aMSC) injected into the vocal folds in 8 patients and aMSC mixed with hyaluronan gel in 8 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- severe hoarseness
- vocal fold scarring
- no active other treatment
- age above 18 years
Key exclusion criteria (3 listed)
- active treatment of laryngeal disorder
- active inflammatory condition of the larynx
- diagnosed or suspicions of local malignancy
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 |
|---|---|---|
| aMSCaMSC injected into the vocal fold of the patient | Biological | aMSC with and without hyaluronan gel |
| aMSC+hyaluronan gelaMSC+ hyaluronan gel is injected into the patients vocal fold | Biological | aMSC with and without hyaluronan gel |
Primary outcome
Improved healing of scarred vocal folds
Time frame: 1 year postoperatively
Laryngeal and general ear, nose, and throat status will be followed for each patient at least one year after primary treatment. This includes examination of signs of local (laryngeal) inflammatory reaction/defect healing, e.g. polyp or granuloma formation, inflammatory reaction after local aMSC injection It also includes repetitive examinations of vocal fold function and voice function including high speed examination of the vocal folds, acoustic voice analysis and phonation pressure measurements as well as subjective ratings by means of Voice handicap index scale
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 25 Feb 2020.
- Derived from this study: PubMed 32197630Hertegard S, Nagubothu SR, Malmstrom E, LeBlanc K. Treatment of vocal fold scarring with autologous bone marrow-derived human mesenchymal stromal cells-first phase I/II human clinical study. Stem Cell Res Ther. 2020 Mar 20;11(1):128. doi: 10.1186/s13287-020-01632-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aMSC and aMSC+hyaluronan gel in people with Improved Healing of Scarred Vocal Folds and Improved Vocal Fold Status, run by Karolinska University Hospital at 1 site in Sweden.
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 3 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 25 Feb 2020. 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 Sweden. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improved healing of scarred vocal folds (time frame: 1 year postoperatively). 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 NCT01981330, 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 25 Feb 2020.