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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04536233
Enrollment
50
Registered
2020-09-02
Start date
2020-10-10
Completion date
2021-03-30
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

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.

Interventions

BIOLOGICALMSCs Derived Pleiotropic Factors

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

OTHERphysiological saline

The physiological saline was injected on the wound

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Wound healing evaluation2 monthsLund-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.

Contacts

Primary ContactMeirong Li, doctor
meirong811225@126.com010-66936345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026