Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

NCT04164485 | Unknown Phase 1

• 1 other identifier: CAS-XDA-LSTR/IGDB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glottic Insufficiency

Outcome Measures

Primary Outcomes (6)

• GRBAS scale

  Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance

  1 week after intervention

• GRBAS scale

  Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance

  1 month after intervention

• GRBAS scale

  Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance

  3 month after intervention

• GRBAS scale

  Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance

  6 month after intervention

• GRBAS scale

  Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance

  9 month after intervention

• GRBAS scale

  Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance

  12 month after intervention

Secondary Outcomes (7)

• Voice handicap index (VHI) scale

  1 week, 1, 3, 6, 9, 12 month after intervention

• Jitter

  1 week, 1, 3, 6, 9, 12 month after intervention

• Shimmer

  1 week, 1, 3, 6, 9, 12 month after intervention

• Normalized noise energy (NNE)

  1 week, 1, 3, 6, 9, 12 month after intervention

• Maximum phonation time (MPT)

  1 week, 1, 3, 6, 9, 12 month after intervention

Study Arms (2)

Functional collagen scaffold transplantation

EXPERIMENTAL

Biological: Functional collagen scaffold transplantation

Autologous adipose cell transplantation

EXPERIMENTAL

Biological: Autologous adipose cell transplantation

Interventions

Functional collagen scaffold transplantation 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

Functional collagen scaffold transplantation

Autologous adipose cell transplantation BIOLOGICAL

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

Autologous adipose cell transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Peking Union Medical College: collaborator

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, 100032, China

RECRUITING

Study Officials

• Jianwu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifeng Xiao, Ph.D

CONTACT

86-10-82614420; zfxiao@genetics.ac.cn

Sufang Han, Ph.D

CONTACT

86-10-82614420; sufanghan22@genetics.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 15, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 15, 2019

Record last verified: 2019-10

Locations

CN (1)