Back to resultsEffects of MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Primary Purpose
MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MSCs Derived Pleiotropic Factors
physiological saline
Sponsored by
About this trial
This is an interventional treatment trial for MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Eligibility Criteria
Inclusion Criteria:
- 18 to 60 years old;
- The clinical diagnosis is nasal trauma, nasal septum deviation, sinusitis, and nasal polyps requiring endoscopic surgery;
- The patient's physical and mental state is stable, and he can return to the hospital regularly for follow-up examinations and cooperate to complete the experiment;
Exclusion Criteria:
- Younger than 18 or older than 60;
- Clinical diagnosis of nasal malignancies, or uncontrolled severe infectious diseases;
- Past medical history of mental illness, malignant tumor, nose surgery;
- People with serious underlying diseases (hypertension, diabetes, rheumatism, asthma) require long-term medication;
- Long-term smoking, more than 5 cigarettes per day;
- Work or daily life environment is exposed to large amounts of dust and chemical raw materials;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
Outcomes
Primary Outcome Measures
Wound healing evaluation
Lund-Kennedy scoring method；under video nasal endoscopy. Including five aspects of polyps, edema, rhinorrhea, scars, and scabs, each score is 0-2 points. Polyp: 0 points means no polyps, 1 point means polyps only in the middle nasal passage, 2 points means polyps beyond the middle nasal passage. Edema: 0 points means no edema, 1 point means mild edema, 2 points means severe edema. Rhinorrhea: 0 points means no rhinorrhea, 1 point means clear and thin nose, 2 points means rhinorrhea is sticky and purulent. Scar: 0 points means no scars, 1 points means mild scars, 2 points means severe scars. Scab formation: 0 points means no scab formation, 1 point means mild scab formation, and 2 points means severe scab formation. Each side 0-10 points, a total of 20 points, the lower the score indicates that the patient's symptoms are lighter.
Secondary Outcome Measures
Full Information
NCT ID
NCT04536233
First Posted
August 30, 2020
Last Updated
September 25, 2020
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04536233
Brief Title
Effects of MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Official Title
The Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Anticipated)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Nasal trauma, deviated nasal septum, sinusitis, nasal polyps and other nasal benign diseases are common clinical diseases and require endoscopic sinus surgery. The proper application of the surgical procedure as well as ensuring high quality of wound healing, is also important to achieve successful results in endoscopic sinus surgery. If good quality wound healing cannot be achieved in the surgical field,synechiae and anatomic defects can occur that may require revision surgeries.
Mesenchymal stem cells play an active role in the treatment of many diseases. it primarily exerts therapeutic effects through paracrine. In this study, the effect of mesenchymal stem cell-derived multipotent factors on mucosal repair after nasal surgery was evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Title
experimental group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MSCs Derived Pleiotropic Factors
Intervention Description
The pleiotropic factor derived from mesenchymal stem cells was injected on the wound
Intervention Type
Other
Intervention Name(s)
physiological saline
Intervention Description
The physiological saline was injected on the wound
Primary Outcome Measure Information:
Title
Wound healing evaluation
Description
Lund-Kennedy scoring method；under video nasal endoscopy. Including five aspects of polyps, edema, rhinorrhea, scars, and scabs, each score is 0-2 points. Polyp: 0 points means no polyps, 1 point means polyps only in the middle nasal passage, 2 points means polyps beyond the middle nasal passage. Edema: 0 points means no edema, 1 point means mild edema, 2 points means severe edema. Rhinorrhea: 0 points means no rhinorrhea, 1 point means clear and thin nose, 2 points means rhinorrhea is sticky and purulent. Scar: 0 points means no scars, 1 points means mild scars, 2 points means severe scars. Scab formation: 0 points means no scab formation, 1 point means mild scab formation, and 2 points means severe scab formation. Each side 0-10 points, a total of 20 points, the lower the score indicates that the patient's symptoms are lighter.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 60 years old;
The clinical diagnosis is nasal trauma, nasal septum deviation, sinusitis, and nasal polyps requiring endoscopic surgery;
The patient's physical and mental state is stable, and he can return to the hospital regularly for follow-up examinations and cooperate to complete the experiment;
Exclusion Criteria:
Younger than 18 or older than 60;
Clinical diagnosis of nasal malignancies, or uncontrolled severe infectious diseases;
Past medical history of mental illness, malignant tumor, nose surgery;
People with serious underlying diseases (hypertension, diabetes, rheumatism, asthma) require long-term medication;
Long-term smoking, more than 5 cigarettes per day;
Work or daily life environment is exposed to large amounts of dust and chemical raw materials;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meirong Li, doctor
Phone
010-66936345
Email
meirong811225@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If there are researchers who need relevant data, they can apply to us
Learn more about this trial
Effects of MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
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