Pilot Study of Stem Cell Treatment of Patients With Vocal Fold Scarring

NCT ID: NCT01981330

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2020-02-24

Brief 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). 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aMSC with and without hyaluronan gel

autologous mesenchymal stem cells (aMSC) injected into the vocal folds in 8 patients and aMSC mixed with hyaluronan gel in 8 patients

Group Type: EXPERIMENTAL

aMSC

Intervention Type: BIOLOGICAL

aMSC injected into the vocal fold of the patient

aMSC+hyaluronan gel

Intervention Type: BIOLOGICAL

aMSC+ hyaluronan gel is injected into the patients vocal fold

Interventions

aMSC

aMSC injected into the vocal fold of the patient

Intervention Type: BIOLOGICAL

aMSC+hyaluronan gel

aMSC+ hyaluronan gel is injected into the patients vocal fold

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• severe hoarseness
• vocal fold scarring
• no active other treatment
• age above 18 years

Exclusion Criteria

• active treatment of laryngeal disorder
• active inflammatory condition of the larynx
• diagnosed or suspicions of local malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Laryngfonden

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stellan Hertegård

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 32197630 (View on PubMed)

Other Identifiers

2010/1650 and 2014-51432

Identifier Type: -

Identifier Source: org_study_id