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Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis

Primary Purpose

Benign Airway Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PRP
Conventional treatment for benign airway stenosis
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Airway Stenosis focused on measuring Platelet-rich plasma, Refractory benign stenosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects with aged between 18 to 75
  2. Subjects diagnosed with refractory benign airway stenosis and meet the following conditions: a. Received two or more (including two) interventional treatments such as laser, high-frequency electrosurgical unit, argon plasma coagulation (APC), cryotherapy, balloon dilation, and metal stent placement. b. Restenosis within 1 month after more than 2 times interventional treatments suffering from repeated granulation hyperplasia of wound
  3. Subjects tolerant to bronchoscopeοΌ›
  4. Subjects signed informed consent

Exclusion Criteria:

  1. Subjects with airway disease:congenital benign central airway stenosis, recurrent polychondritis, etc;
  2. Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
  3. Subjects with malignant tumors or have a history of malignant tumors;
  4. Subjects with uncontrolled systemic infection;
  5. Subjects requiring anti-clotting drugs;
  6. Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc;
  7. Subjects with syphilis, HIV,HBV,HCV antibody positive;
  8. Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc;
  9. Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value;
  10. Subjects with liver disease or liver damage: ALT,AST, total bilirubin > 2 times the upper limit of the normal value;
  11. Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases;
  12. Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction;
  13. Subjects allergic to thrombin;
  14. Subjects accepted by any other clinical study within the first three months of the study;
  15. Subjects with poor compliance;
  16. Any other conditions might increase the risk of the patient or interfere with the clinical study.

Sites / Locations

  • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

PRP group

Arm Description

Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement

Procedure/Surgery: PRP PRP treatment following the conventional treatment Slow spray / inject autogenous PRP to cover the wound of stenosis. Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement

Outcomes

Primary Outcome Measures

Cure rate for benign stenosis
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment

Secondary Outcome Measures

Clinical remission time
The interval time of the first intratracheal interventional therapy needed again after 6 times of PRP treatment
Times of unplanned treatment
The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea
Incidence of complications associated with PRP treatment
Wound healing, sputum retention, etc. during follow-up

Full Information

First Posted
March 26, 2019
Last Updated
March 26, 2019
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT03892837
Brief Title
Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis
Official Title
Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Platelet-rich plasma(PRP), is a concentrate of platelet-rich plasma protein derived from whole blood. The main components of it are platelets, leukocytes and fibrin. Autologous PRP treatment can avoid the immune rejection caused by exogenous growth factor and the spread of disease. Evidence of the efficacy and safety of PRP has been proven in many studies. Benign central airway stenosis is characterized by airway compromise involving the larynx, trachea, or bronchi and will lead to devastating consequences. Unfortunately, the incidence of this disease is increasing steadily. As most important treatment for benign airway stenosis, respiratory intervention has become one of the most common treatments to fight the disease. However, the restenosis caused by tissue hyperplasia, wound repair and scar formation after treatment is still common, which remains the limitation of respiratory intervention. Long-term efficacy of repeated interventional treatment is unsatisfying, too. Several studies have discovered similar mechanism between stenosis of tracheal to hyperplastic scar of skin, both of which are relative with deep structure injury such as the intrinsic layer of airway mucosa. PRP has shown significant efficacy for hyperplastic scar of skin. Correspondingly, PRP will be applied as treatment of refractory benign airway stenosis to reduce restenosis by inhibit the formation of granulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Airway Stenosis
Keywords
Platelet-rich plasma, Refractory benign stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
Arm Title
PRP group
Arm Type
Experimental
Arm Description
Procedure/Surgery: PRP PRP treatment following the conventional treatment Slow spray / inject autogenous PRP to cover the wound of stenosis. Procedure/Surgery: Conventional therapy of airway stenosis is including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
Intervention Type
Procedure
Intervention Name(s)
PRP
Intervention Description
PRP treatment following the conventional treatment for benign airway stenosis which contain a concentrate of platelet-rich plasma protein derived from whole blood.
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment for benign airway stenosis
Intervention Description
Including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
Primary Outcome Measure Information:
Title
Cure rate for benign stenosis
Description
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
Time Frame
within 6 months after administration
Secondary Outcome Measure Information:
Title
Clinical remission time
Description
The interval time of the first intratracheal interventional therapy needed again after 6 times of PRP treatment
Time Frame
6 months after administration
Title
Times of unplanned treatment
Description
The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea
Time Frame
within 6 months after administration
Title
Incidence of complications associated with PRP treatment
Description
Wound healing, sputum retention, etc. during follow-up
Time Frame
within 6 months after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with aged between 18 to 75 Subjects diagnosed with refractory benign airway stenosis and meet the following conditions: a. Received two or more (including two) interventional treatments such as laser, high-frequency electrosurgical unit, argon plasma coagulation (APC), cryotherapy, balloon dilation, and metal stent placement. b. Restenosis within 1 month after more than 2 times interventional treatments suffering from repeated granulation hyperplasia of wound Subjects tolerant to bronchoscopeοΌ› Subjects signed informed consent Exclusion Criteria: Subjects with airway disease:congenital benign central airway stenosis, recurrent polychondritis, etc; Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc; Subjects with malignant tumors or have a history of malignant tumors; Subjects with uncontrolled systemic infection; Subjects requiring anti-clotting drugs; Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc; Subjects with syphilis, HIV,HBV,HCV antibody positive; Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc; Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value; Subjects with liver disease or liver damage: ALT,AST, total bilirubin > 2 times the upper limit of the normal value; Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases; Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction; Subjects allergic to thrombin; Subjects accepted by any other clinical study within the first three months of the study; Subjects with poor compliance; Any other conditions might increase the risk of the patient or interfere with the clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyue Li, MD
Phone
86-020-83062885
Email
lishiyue@188.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobo Chen, MD
Phone
86-020-83062885
Email
xiaobo-win@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
Phone
8620-83062896
Email
lishiyue@188.com
First Name & Middle Initial & Last Name & Degree
Xiaobo Chen, MD
Phone
8620-83062885
Email
xiaobo-win@163.com
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD
First Name & Middle Initial & Last Name & Degree
Xiaobo Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis

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