Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Unilateral vocal cord paralysis (UVCP) is a clinical condition and often leads to glottic insufficiency. The presence of glottic insufficiency can result in poor pronunciation quality, vocal fatigue, shortness of breath with speaking, and in some cases, it could lead to unable to pronounce, dysphagia and aspiration, severely decreasing quality of life for its victims. This study is carried out to explore the short-term and long-term efficacy of the functional collagen scaffold in guiding laryngeal soft tissue regeneration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold

NCT02754284

Vocal Cord Dysfunction

COMPLETED PHASE1

Voice and Swallow Outcomes After Office-based Injection Laryngoplasty in Patients With Glottal Insufficiency

NCT06161064

Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency

NOT_YET_RECRUITING NA

Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.

NCT02973152

Vocal Cord Paralysis Unilateral

COMPLETED PHASE2

Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

NCT00213863

Vocal Cord Paralysis

UNKNOWN PHASE2

Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches

NCT00600223

Larynx Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glottic Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Functional collagen scaffold transplantation

Group Type EXPERIMENTAL

Functional collagen scaffold transplantation

Intervention Type BIOLOGICAL

Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope

Autologous adipose cell transplantation

Group Type EXPERIMENTAL

Autologous adipose cell transplantation

Intervention Type BIOLOGICAL

Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional collagen scaffold transplantation

Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope

Intervention Type BIOLOGICAL

Autologous adipose cell transplantation

Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age of 18-65 years old, male or female
2. Unilateral vocal cord injury and poor closure of the glottis
3. Disease course was more than 1 year
4. At least two GRBAS scores reach 2 points or more
5. The subjects have read and fully understood the research notes, signed informed consent

Exclusion Criteria

1. Over speaking professionals, such as teachers, shop assistants
2. With vital organ dysfunction, such as heart, lung, liver or kidney
3. With malignant tumors
4. Pregnant or lactating women, or in preconception period
5. History of drug allergy
6. Difficult to be followed-up or cooperate long-termly
7. Participated in other clinical trials in the last 3 months
8. With severe progressive diseases
9. Alcoholics or drug addicts
10. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers
11. With inevitable circumstances of voice damage
12. Any other unsuitable conditions for the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No