Effects of MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

The Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

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.

Study Overview

• Status: Unknown
• Conditions: MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
• Intervention / Treatment: Other: physiological saline; Biological: MSCs Derived Pleiotropic Factors

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 to 60 years old;
2. The clinical diagnosis is nasal trauma, nasal septum deviation, sinusitis, and nasal polyps requiring endoscopic surgery;
3. 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:

1. Younger than 18 or older than 60;
2. Clinical diagnosis of nasal malignancies, or uncontrolled severe infectious diseases;
3. Past medical history of mental illness, malignant tumor, nose surgery;
4. People with serious underlying diseases (hypertension, diabetes, rheumatism, asthma) require long-term medication;
5. Long-term smoking, more than 5 cigarettes per day;
6. Work or daily life environment is exposed to large amounts of dust and chemical raw materials;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Biological: MSCs Derived Pleiotropic Factors; The pleiotropic factor derived from mesenchymal stem cells was injected on the wound
Placebo Comparator: control group	Other: physiological saline; The physiological saline was injected on the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2020
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CHIN-PLAGH-MP-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If there are researchers who need relevant data, they can apply to us

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No