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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 1

Conditions: MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

Treatments: Other: physiological saline; Biological: MSCs Derived Pleiotropic Factors

Study type: Interventional

Funder types: Other

Identifiers

NCT04536233

CHIN-PLAGH-MP-05

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Treatment:

Other: physiological saline

experimental group

Experimental group

Treatment:

Biological: MSCs Derived Pleiotropic Factors