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Extracellular Vesicles
Stem Cell-Derived Therapy for Burns
Phase 1
Recruiting
Research Sponsored by Aegle Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Index burn injury within the prior 48 hours
Eighteen years of age or older with deep second degree thermal burn wounds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial studies the use of stem cells to treat deep skin burns, to reduce scarring and improve healing.
Who is the study for?
Adults with deep second-degree thermal burns covering a total area less than 300 cm2, sustained within the last 24 hours. Participants must be able to attend treatment sessions and agree to contraception if applicable. Excluded are those with burns over scars, expected quick healing, infections at wound site, certain medical conditions including severe coagulopathy or cardiopulmonary disease, substance abuse history within a year, life expectancy under two years, specific blood count abnormalities, allergy to human albumin or certain antibiotics.Check my eligibility
What is being tested?
The trial is testing AGLE-102 extracellular vesicles from bone marrow stem cells on patients with serious burn wounds. The goal is to see if these vesicles can help heal the skin better than current treatments. Patients will receive this new therapy directly on their wounds and will be monitored for effectiveness and safety.See study design
What are the potential side effects?
Potential side effects of AGLE-102 may include local reactions at the application site such as redness or irritation. Since it's a biological product derived from stem cells there might also be risks of immune reactions or infection transmission although specifics aren't provided.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My burn injury happened within the last 2 days.
Select...
I am 18 or older with deep second-degree burns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Examine the safety of applying up to three applications of EVs to deep 2nd degree burn wounds up to 600 cm2
Secondary outcome measures
Determine if administration of EVs can promote wound healing by serial wound measurements
Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AGLE-102Experimental Treatment1 Intervention
AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs)
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Who is running the clinical trial?
Aegle TherapeuticsLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
48 Previous Clinical Trials
6,766 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe heart or lung condition that limits my ability to walk.I am using or willing to use birth control or I am not of childbearing age.My burn wounds need surgery or skin grafting beyond simple cleaning.I am currently pregnant or breastfeeding.I have an infection at the site of my wound.My wound is between 30 cm2 and 600 cm2 in size.I have a cancer other than non-melanoma skin cancer that is not in remission or has been in remission for less than 5 years.I can attend all appointments for wound care and check-ups.I need to take steroids or medications that suppress my immune system.My wound is only on my fingers, toes, face, or perineum.My burn injury happened within the last 2 days.I have a known blood clotting disorder.I am 18 or older with deep second-degree burns.My wound crosses over half of one or more of my joints.My wounds have significantly healed before starting treatment.I have a second degree burn expected to heal in 2 weeks with standard care.I have had chemical, radiation, or electrical burns.
Research Study Groups:
This trial has the following groups:- Group 1: AGLE-102
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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