Benign Airway StenosisNCT03892837
Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis
A study testing PRP and Conventional treatment for benign airway stenosis in people with Benign Airway Stenosis, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Benign Airway Stenosis
- What is being tested?
- PRP and Conventional treatment for benign airway stenosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Apr 2019to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 bronchoscope；
- Subjects signed informed consent
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Shiyue Li, MD, 8620-83062896, lishiyue@188.com
Xiaobo Chen, MD, 8620-83062885, xiaobo-win@163.com
About this study
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.
- Conditions
- Benign Airway Stenosis
- Being tested
- PRP, Conventional treatment for benign airway stenosis
- Keywords
- Platelet-rich plasma, Refractory benign stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPProcedure or surgery
PRP treatment following the conventional treatment for benign airway stenosis which contain a concentrate of platelet-rich plasma protein derived from whole blood.
Conventional treatment for benign airway stenosisProcedure or surgery
Including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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 Receives: Procedure: Conventional treatment for benign airway stenosis |
| PRP group | Experimental | 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 Receives: Procedure: PRP; Procedure: Conventional treatment for benign airway stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate for benign stenosis
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
Measured: within 6 months after administration
Secondary outcomes (3)
Clinical remission time
The interval time of the first intratracheal interventional therapy needed again after 6 times of PRP treatment
Measured: 6 months after administration
Times of unplanned treatment
The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea
Measured: within 6 months after administration
Incidence of complications associated with PRP treatment
Wound healing, sputum retention, etc. during follow-up
Measured: within 6 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Airway StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, MD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892837
- Sponsor's protocol ID
- 2019-03-06
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Refractory Benign Airway Stenosis
- ClinicalTrials.gov ID
- NCT03892837
- Acronym / sponsor ID
- 2019-03-06
- Conditions
- Benign Airway Stenosis
- Keywords
- Platelet-rich plasma, Refractory benign stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Conventional treatment for benign airway stenosisProcedure/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 |
| PRP group | Experimental | Procedure: PRP, Procedure: Conventional treatment for benign airway stenosisProcedure/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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 bronchoscope；
- Subjects signed informed consent
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPPRP treatment following the conventional treatment for benign airway stenosis which contain a concentrate of platelet-rich plasma protein derived from whole blood. | Procedure or surgery | PRP group |
| Conventional treatment for benign airway stenosisIncluding, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement | Procedure or surgery | Control group, PRP group |
Primary outcome
Cure rate for benign stenosis
Time frame: within 6 months after administration
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
3 secondary outcomes
Clinical remission time
Time frame: 6 months after administration
Times of unplanned treatment
Time frame: within 6 months after administration
Incidence of complications associated with PRP treatment
Time frame: within 6 months after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No
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Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyue Li, MD principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP and Conventional treatment for benign airway stenosis in people with Benign Airway Stenosis, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, MD (86-020-83062885, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate for benign stenosis (time frame: within 6 months after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.