Safety of Extracellular Vesicles for Burn Wounds

November 19, 2024 updated by: Aegle Therapeutics

A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Ryder Trauma Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • North Carolina Jaycee Burn Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Eighteen years of age or older with deep second degree thermal burn wounds
  2. Index burn injury within the prior 72 hours
  3. Subjects must understand and be willing and able to give written informed consent
  4. Subjects must agree to have blood draws performed per protocol
  5. Subjects must be accessible for wound treatment and assessment visits
  6. Males and females must agree to use an acceptable method of contraception. Exceptions will be females of non-childbearing age and monogamous males who are partners of females of non-childbearing age. Acceptable methods of birth control include; history of sterilization, oral contraceptives, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide cream or gel, or an intrauterine device (IUD).
  7. Maximum index wound size at screening limited to single or multiple wounds (in a defined anatomical area) cumulatively ≤ 600 cm2. Minimum wound size at screening: 30 cm2. Other wounds may be present that are treated separately from this protocol subject to the maximum TBSA exclusion criteria listed below.

Exclusion Criteria:

  1. Solely first degree or solely third degree burns
  2. Cumulative burn area ≥ 20% TBSA (20% TBSA corresponds to 3700 cm2 in a 70 kg, 175 cm subject)
  3. Burns that occur over a previous scar
  4. Chemical, radiation, or electrical burns
  5. Subjects with superficial second degree burn who are expected to heal within 2 weeks with standard therapy
  6. Evidence of active infection at the wound site
  7. Evidence of significant wound healing prior to treatment
  8. Burn wounds requiring surgery (other than debridement), or skin grafting
  9. Wound exclusively located in the area of fingers, toes, face, or perineum
  10. Wound that extends > 50% across one or more joints
  11. Have any requirement for the use of systemic steroids or immunosuppressive medications
  12. Subjects allergic to human albumin, streptomycin, or penicillin
  13. Be a pregnant female or nursing mother
  14. Subjects who are known or found to be HIV positive
  15. History of alcohol or substance abuse requiring treatment within the past 12 months.

  16. Severe medical conditions

    1. Malignancy (other than non-melanoma skin cancer) not in remission or in remission less than 5 years
    2. Life expectancy less than two years
    3. Severe cardiopulmonary disease restricting ambulation to the clinical facility
  17. WBC <3 or > 20 x109/L, Hgb < 9g/dL, platelet count 100x109/L or less, serum creatinine > 1.5 times the upper normal limit, AST or ALT > 2.4 times upper normal limit
  18. Known history of coagulopathy
  19. Subjects who have a reasonable likelihood of being a recipient of tissue or organ transplantation
  20. History of poor compliance, unreliability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AGLE-102
AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs)
Drug: AGLE-102
AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Examine the safety of applying up to three applications of EVs to deep 2nd degree burn wounds up to 600 cm2
Time Frame: 1 year
Examine the safety of applying up to three applications of EVs to deep 2nd degree burn wounds up to 600 cm2 by evaluating the number of participants with treatment-related adverse events as assessed cy CTCAE v4.0
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine if administration of EVs can promote wound healing by serial wound measurements
Time Frame: 8 weeks
Determine if administration of EVs can promote wound healing by serial wound measurements; tissue regeneration as evidenced by restoration of pigmentation and hair growth by serial photography; and skin texture assessment the Patient and Observer Scar Assessment Scale (scale of 1 to 10, where 10 is a worse outcome).
8 weeks
Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.
Time Frame: 1 year
Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aegle Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Congressionally Directed Medical Research Programs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carl Schulman, MD, Ryder Trauma Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGLE-102-102

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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