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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2021-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

Group Type PLACEBO_COMPARATOR

physiological saline

Intervention Type OTHER

The physiological saline was injected on the wound

experimental group

Group Type EXPERIMENTAL

MSCs Derived Pleiotropic Factors

Intervention Type BIOLOGICAL

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

Interventions

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MSCs Derived Pleiotropic Factors

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

Intervention Type BIOLOGICAL

physiological saline

The physiological saline was injected on the wound

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes