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

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

NCT ID: NCT06391307

Condition: Pilonidal Sinus
Pilonidal Disease

Conditions: Official terms:
Pilonidal Sinus
Paranasal Sinus Diseases
Phenol

Conditions: Keywords:
pilonidal sinus disease
Children
wound healing
stem cell
exosome

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Crystallized phenol
Description: Crystallized phenol + Exosome + Stem Cell
Arm group label: Crystallized phenol

Other name: Crystallized phenol will be applied to wound area.

Intervention type: Biological
Intervention name: Crystallized phenol + Exosome
Description: Crystallized phenol + Exosome will be applied to wound area.
Arm group label: Crystallized phenol + Exosome

Intervention type: Biological
Intervention name: Crystallized phenol + Stem Cell
Description: Crystallized phenol + Stem cell will be applied to wound area.
Arm group label: Crystallized phenol + Stem Cell

Intervention type: Biological
Intervention name: Crystallized phenol + Exosome + Stem Cell
Description: Crystallized phenol + Exosome + Stem Cell will be applied to wound area.
Arm group label: Crystallized phenol + Exosome + Stem Cell

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).

Detailed description: Pilonidal sinus disease (PSD) is an infectious or inflammatory condition beneath the skin at the peak of the gluteal cleft in the sacrococcygeal area. It is a chronic condition characterized by discharge, infection, and pain. Although it can occur during adolescence, it is most commonly seen in adult males, leading to a focus on adult treatments in research. Surgical treatment was first implemented by Anderson in 1847. Since then, various surgical and medical treatment options have been explored, yet there is no widely accepted standardized treatment. The ideal treatment should be simple, require a short hospital stay, have low recurrence rates, provide good cosmetic results, be cost-effective, cause minimal pain, and allow a quick return to social life, making the surgical approach contentious. Maurice and Greenwood first reported the application of liquid phenol in 1964, initially under general anesthesia, later shifting to local anesthesia. Due to high recurrence rates with liquid phenol, Dogru and colleagues introduced the crystallized phenol (CP) procedure, a minimally invasive method now commonly used in adults. Recent years have shown that stem cells and exosomes promote tissue healing and reduce inflammation. Known for their ability to differentiate into various cell types, stem cells, and exosomes play critical roles in intercellular communication, containing a variety of molecules. Their use in surgical fields has become popular as they speed up the post-operative healing process and reduce the risk of complications. Research in the literature supports that stem cells and exosomes accelerate wound healing (e.g., Nourian Dehkordi A, et al. 2019). This study is based on two main premises: firstly, to identify the potential healing effects of stem cell and exosome applications in treating pilonidal sinus disease; and secondly, to comparatively assess the impact of these applications on surgical outcomes, specifically regarding surgery duration, complications, and the healing process. Comparing these two groups will help determine the value of stem cell and exosome applications in managing pilonidal sinus disease.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 0-18 years children. - Patients with chronic non-healing wound and pilonidal sinus diseases. Exclusion Criteria: - Patients with epilepsia - Patients with diabetes - Patients with hypertension - Patients with chronic other diseases.

Gender: All

Minimum age: 1 Day

Maximum age: 18 Years

Healthy volunteers: No

Locations:

Facility:
Name: Mustafa Azizoğlu

Address:
City: Istanbul
Zip: 34430
Country: Turkey

Status: Recruiting

Contact:
Last name: Mustafa Azizoğlu

Phone: +905447448244
Email: mdmazizoglu@gmail.com

Start date: May 11, 2024

Completion date: December 30, 2024

Lead sponsor:
Agency: Mustafa Azizoğlu
Agency class: Other

Collaborator:
Agency: Necmi Kadıoğlu Hospital
Agency class: Other

Source: Necmi Kadıoğlu Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06391307