CClinicalTrials.gg
Status unknownNCT03892837Updated Mar 27, 2019

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

An interventional study of PRP and Conventional treatment for benign airway stenosis in Benign Airway Stenosis, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-27.

Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Benign Airway Stenosis

Keywords

  • Platelet-rich plasma
  • Refractory benign stenosis
03

In context

Constriction, Pathologic

1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.

This study's planned enrollment of 24 is below the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 bronchoscope;
  4. Subjects signed informed consent

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Control group

    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: Conventional treatment for benign airway stenosis

  • Experimental
    PRP group

    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

    Procedure: PRP · Procedure: Conventional treatment for benign airway stenosis

Interventions

  • ProcedurePRP

    PRP treatment following the conventional treatment for benign airway stenosis which contain a concentrate of platelet-rich plasma protein derived from whole blood.

  • ProcedureConventional treatment for benign airway stenosis

    Including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement

06

What researchers measure

Primary outcomes

  1. Cure rate for benign stenosis

    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 outcomes

  1. Clinical remission time

    The interval time of the first intratracheal interventional therapy needed again after 6 times of PRP treatment

    Time frame: 6 months after administration

  2. Times of unplanned treatment

    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

  3. Incidence of complications associated with PRP treatment

    Wound healing, sputum retention, etc. during follow-up

    Time frame: within 6 months after administration

07

Study locations

1 site
  • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
    • Shiyue Li, MD · Contact · lishiyue@188.com · 8620-83062896
    • Xiaobo Chen, MD · Contact · xiaobo-win@163.com · 8620-83062885
    • Shiyue Li, MD · Principal investigator
    • Xiaobo Chen, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03892837
Lead sponsor
Guangzhou Institute of Respiratory Disease
Responsible party
ShiYue Li (Director of Department of Respiratory Medicine, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
Mar 27, 2019
Start date
Apr 2019 (estimated)
Primary completion
Sep 2020 (estimated)
Completion
Apr 2021 (estimated)
Last update
Mar 27, 2019

Study contacts

Shiyue Li, MD
Contact
lishiyue@188.com
86-020-83062885
Xiaobo Chen, MD
Contact
xiaobo-win@163.com
86-020-83062885
Shiyue Li, MD
principal investigator · Guangzhou Institute of Respiratory Disease

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion