RecruitingNot ApplicableNCT06391307

The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children

The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial


Sponsor

Mustafa Azizoğlu

Enrollment

120 participants

Start Date

May 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Chronic wounds that fail to heal over extended periods pose a significant financial burden on the healthcare system, underscoring the urgent need to enhance clinical treatments. Among the most promising approaches are stem cell-based therapies. Substantial evidence suggests that mesenchymal stem cells (MSCs) can facilitate the healing of chronic wounds in both animal models and preclinical studies, primarily through their paracrine actions. The bioactive factors and cytokines secreted by MSCs can be harvested in the form of conditioned medium. This medium has been processed into a lyophilized powder for clinical use. Patients with chronic wounds will recruited and divided into two groups: the control group will receive the commonly used fibroblast growth factor, while the experimental group was treated with the lyophilized powder. The study aims to assess the efficacy and safety of this Stem cell and exosome in treating chronic wounds (especially pilonidal sinus).


Eligibility

Min Age: 1 DayMax Age: 18 Years

Inclusion Criteria2

  • -18 years children.
  • Patients with chronic non-healing wound and pilonidal sinus diseases.

Exclusion Criteria4

  • Patients with epilepsia
  • Patients with diabetes
  • Patients with hypertension
  • Patients with chronic other diseases.

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Interventions

OTHERCrystallized phenol

Crystallized phenol + Exosome + Stem Cell

BIOLOGICALCrystallized phenol + Exosome

Crystallized phenol + Exosome will be applied to wound area.

BIOLOGICALCrystallized phenol + Stem Cell

Crystallized phenol + Stem cell will be applied to wound area.

BIOLOGICALCrystallized phenol + Exosome + Stem Cell

Crystallized phenol + Exosome + Stem Cell will be applied to wound area.


Locations(1)

Mustafa Azizoğlu

Istanbul, Turkey (Türkiye)

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NCT06391307


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