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

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391307
• Other study ID #: Stem Cell PNS
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Necmi Kadioglu Hospital
• Contact: Mustafa Azizoglu, MD, PhD
• Phone: +905447448244
• Email: mdmazizoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paranasal Sinus Diseases
• Pilonidal Disease
• Pilonidal Sinus

Intervention

Other:
• Crystallized phenol
Crystallized phenol + Exosome + Stem Cell

Biological:
• Crystallized phenol + Exosome
Crystallized phenol + Exosome will be applied to wound area.
• Crystallized phenol + Stem Cell
Crystallized phenol + Stem cell will be applied to wound area.
• Crystallized phenol + Exosome + Stem Cell
Crystallized phenol + Exosome + Stem Cell will be applied to wound area.

Locations

Country	Name	City	State
Turkey	Mustafa Azizoglu	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Mustafa Azizoglu	Necmi Kadioglu Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing time	In the control group, the healing process generally takes about 2-3 weeks. In the experimental group, a shorter duration is expected. In this study, the wound healing times of both groups will be evaluated and compared.	3 weeks
Primary	Cosmetic results	In this study, the worst healing wounds will receive a score of 1, and the best-healed wounds, which are closest to normal skin, will receive a score of 10. In short, a low score indicates poor wound healing and poor cosmetic, while a high score indicates that the wound has achieved a good cosmetic appearance.	2 month
Primary	Skin burn rate	In patients treated with crystallized phenol, skin burns can occur during application. To prevent this, Furacin ointment is applied around the wound. However, we still encounter skin burns. In this study, it is expected that the experimental groups will have a lower burn rate compared to the control group. The burn rate will be evaluated in this study.	2 weeks
Primary	Average time to full daily activities	It refers to the time when patients return to their routine lives after the procedure.	1 week
Primary	VAS score	Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days, 20 days following the procedure and after recovery.	7 weeks
Primary	Success rate	The succes rate will be calculated after interventions	7 weeks
Primary	Recurrence rate	The recurrence rate will be calculated after interventions	7 weeks
Secondary	Bleeding rate	Bleeding during interventions will be calculated	1 week
Secondary	Infection rate	Infection will be defined during interventions and 10 days after intervention	7 week
Secondary	Total complication rate	Total complicaitons during interventions will be calculated	7 weeks