Burns Clinical Trial - Safety of Extracellular Vesicles for Burn Wounds

Status Recruiting

Clinical Trial Summary

Treatment of patients with deep second degree burns of the skin with extracellular vesicles (EV) isolated from bone marrow derived mesenchymal stem cells.

Clinical Trial Description

This study is designed to examine the safety and efficacy, in 10 patients of administration of allogeneic MSC EV to deep second degree burn wounds. The dose level delivered will be approximately 1 X 107 EV particles for each cm2 treated area. Wounds eligible for treatment will not exceed 600 cm2 per wound or collection of wounds in a defined anatomical area (e.g., arm, leg, chest) treated. Patients with 20% or greater TBSA in total (3700 cm2 in a 70 kg, 175 cm subject) will be ineligible to participate in the study. The first treatment will be administered within 48 hours of the burn injury. Two additional administrations of EV will be given approximately one week (day 5-7 post-injury) and two weeks after the first treatment (unless the wound is fully closed, in which case the patient will continue to be monitored at weekly intervals through 5 weeks, then at 8, 12, 26, and 54 weeks). Safety will be assessed by collection of adverse event data. The potential for wound healing efficacy will be evaluated by recording the percent of burns re-epithelialized within 8 weeks as well as the time to complete closure. Wound closure will be defined as complete re-epithelialization that is not subject to re-injury during dressing changes or as a result of normal daily activities (e.g., wearing clothing, eating, sleeping). The potential for tissue regeneration and restoration of pigmentation, hair growth and skin texture will be evaluated by scoring healing and scar formation using POSAS. Assessment of the potential for prevention of conversion will be done using LDI. Deep second degree wounds presenting at screening that are assessed to be deeper by LDI at the 5-7 day reading than at the initial evaluation in the first 72 hours will be considered to have undergone conversion. Exploratory endpoints will include monitoring for the presence of an immunologic response in recipients. ;

Study Design

Related Conditions & MeSH terms

Burns

Clinical Trial Details

NCT number	NCT05078385
Study type	Interventional
Source	Aegle Therapeutics
Contact	Shelley Hartman
Phone	781-918-8849
Email	shartman@aegletherapeutics.com
Status	Recruiting
Phase	Phase 1
Start date	August 10, 2023
Completion date	June 2025

View Details

See also
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Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
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Recruiting	`NCT02904941` - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns	N/A
Completed	`NCT02681757` - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns	N/A
Recruiting	`NCT01812941` - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients	N/A
Completed	`NCT01437852` - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns	Phase 1
Completed	`NCT01214811` - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing	Phase 3
Completed	`NCT01061502` - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds	Phase 1/Phase 2
Terminated	`NCT00822796` - Thermogard™ Efficacy Trial	N/A
Terminated	`NCT00824681` - Effect of Music Therapy on Families of Burn Patients	Phase 1
Terminated	`NCT00634166` - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group	Phase 4
Terminated	`NCT00464386` - Continuous Glucose Monitoring (POC) in the ICU	N/A
Withdrawn	`NCT00216983` - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.