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

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 18
Healthy Volunteers: f
View:

• 0-18 years children.

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

Locations
Other Locations
Turkey
Mustafa Azizoğlu
RECRUITING
Istanbul
Contact Information
Primary
Mustafa Azizoğlu, MD, PhD
mdmazizoglu@gmail.com
+905447448244
Time Frame
Start Date: 2024-05-11
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Crystallized phenol
In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol into the wound.
Experimental: Crystallized phenol + Exosome
In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Exosome into the wound.
Experimental: Crystallized phenol + Stem Cell
In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell into the wound.
Experimental: Crystallized phenol + Exosome + Stem Cell
In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell + Exosome into the wound.
Related Therapeutic Areas
Sponsors
Collaborators: Necmi Kadıoğlu Hospital
Leads: Mustafa Azizoğlu

This content was sourced from clinicaltrials.gov