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

NCT04536233 | Unknown Phase 1

• 1 other identifier: CHIN-PLAGH-MP-05
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control group

PLACEBO COMPARATOR

Other: physiological saline

experimental group

EXPERIMENTAL

Biological: MSCs Derived Pleiotropic Factors

Interventions

MSCs Derived Pleiotropic Factors BIOLOGICAL

The pleiotropic factor derived from mesenchymal stem cells was injected on the wound

experimental group

physiological saline OTHER

The physiological saline was injected on the wound

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Central Study Contacts

Meirong Li, doctor

CONTACT

010-66936345; meirong811225@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 2, 2020
• Study Start: October 10, 2020
• Primary Completion: January 31, 2021
• Study Completion: March 30, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-09