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

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).

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus; Pilonidal Disease
• Intervention / Treatment: Other: Crystallized phenol; Biological: Crystallized phenol + Exosome; Biological: Crystallized phenol + Stem Cell; Biological: Crystallized phenol + Exosome + Stem Cell

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa Azizoglu, MD, PhD; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34430
    • Recruiting
    • Mustafa Azizoğlu
    • Contact: Mustafa Azizoğlu; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Crystallized phenol; Crystallized phenol + Exosome + Stem Cell; Other Names: Crystallized phenol will be applied to wound area.
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.	Biological: Crystallized phenol + Exosome; Crystallized phenol + Exosome will be applied to wound area.
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.	Biological: Crystallized phenol + Stem Cell; Crystallized phenol + Stem cell will be applied to wound area.
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.	Biological: Crystallized phenol + Exosome + Stem Cell; Crystallized phenol + Exosome + Stem Cell will be applied to wound area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average time to full daily activities	It refers to the time when patients return to their routine lives after the procedure.	1 week
Success rate	The succes rate will be calculated after interventions	7 weeks
Recurrence rate	The recurrence rate will be calculated after interventions	7 weeks
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding rate	Bleeding during interventions will be calculated	1 week
Total complication rate	Total complicaitons during interventions will be calculated	7 weeks
Infection rate	Infection will be defined during interventions and 10 days after intervention	7 week

Collaborators and Investigators

• Sponsor: Mustafa Azizoğlu
• Collaborators: Necmi Kadıoğlu Hospital
• Investigators: Principal Investigator: Mustafa Azizoğlu, MD, Esenyurt State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Children; stem cell; wound healing; exosome; pilonidal sinus disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Cysts; Otorhinolaryngologic Diseases; Nose Diseases; Pilonidal Sinus; Paranasal Sinus Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Disinfectants; Sclerosing Solutions; Phenol
• Other Study ID Numbers: Stem Cell PNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No