Clinical trial NCT04164485: Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration
Official title: Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glottic Insufficiency
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Peking Union Medical College
First posted: 2019-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: GRBAS scale
timeFrame: 1 week after intervention
measure: GRBAS scale
timeFrame: 1 month after intervention
measure: GRBAS scale
timeFrame: 3 month after intervention
measure: GRBAS scale
timeFrame: 6 month after intervention
measure: GRBAS scale
timeFrame: 9 month after intervention
measure: GRBAS scale
timeFrame: 12 month after intervention
Secondary outcomes:
measure: Voice handicap index (VHI) scale
timeFrame: 1 week, 1, 3, 6, 9, 12 month after intervention
measure: Jitter
timeFrame: 1 week, 1, 3, 6, 9, 12 month after intervention
measure: Shimmer
timeFrame: 1 week, 1, 3, 6, 9, 12 month after intervention
measure: Normalized noise energy (NNE)
timeFrame: 1 week, 1, 3, 6, 9, 12 month after intervention
measure: Maximum phonation time (MPT)
timeFrame: 1 week, 1, 3, 6, 9, 12 month after intervention
measure: Physical status of vocal cords
timeFrame: 1 week, 1, 3, 6, 9, 12, 24 month after intervention
measure: Volume of vocal cords
timeFrame: Baseline, 1 year, 2 year after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: