BurnsPhase 1NCT05078385
Safety of Extracellular Vesicles for Burn Wounds
A Phase 1 study testing AGLE-102 in people with Burns, run by Aegle Therapeutics at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- AGLE-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2023to 19 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen years of age or older with deep second degree thermal burn wounds
- Index burn injury within the prior 72 hours
- Subjects must understand and be willing and able to give written informed consent
- Subjects must agree to have blood draws performed per protocol
- Subjects must be accessible for wound treatment and assessment visits
- 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).
- 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.
Who cannot join
- Solely first degree or solely third degree burns
- Cumulative burn area ≥ 20% TBSA (20% TBSA corresponds to 3700 cm2 in a 70 kg, 175 cm subject)
- Burns that occur over a previous scar
- Chemical, radiation, or electrical burns
- Subjects with superficial second degree burn who are expected to heal within 2 weeks with standard therapy
- Evidence of active infection at the wound site
Show all 23Show fewer
- Evidence of significant wound healing prior to treatment
- Burn wounds requiring surgery (other than debridement), or skin grafting
- Wound exclusively located in the area of fingers, toes, face, or perineum
- Wound that extends > 50% across one or more joints
- Have any requirement for the use of systemic steroids or immunosuppressive medications
- Subjects allergic to human albumin, streptomycin, or penicillin
- Be a pregnant female or nursing mother
- Subjects who are known or found to be HIV positive
- History of alcohol or substance abuse requiring treatment within the past 12 months.
- Severe medical conditions
- Malignancy (other than non-melanoma skin cancer) not in remission or in remission less than 5 years
- Life expectancy less than two years
- Severe cardiopulmonary disease restricting ambulation to the clinical facility
- 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
- Known history of coagulopathy
- Subjects who have a reasonable likelihood of being a recipient of tissue or organ transplantation
- History of poor compliance, unreliability
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, 27599
Ryder Trauma Center
Miami, Florida, 33136
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns
- Being tested
- AGLE-102
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGLE-102Drug
AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs)
| Study group | Role | What they receive |
|---|---|---|
| AGLE-102 | Experimental | AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs) Receives: Drug: AGLE-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the safety of applying up to three applications of EVs to deep 2nd degree burn wounds up to 600 cm2
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
Measured: 1 year
Secondary outcomes (2)
Determine if administration of EVs can promote wound healing by serial wound measurements
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).
Measured: 8 weeks
Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.
Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start10 Aug 2023
- Primary completion5 Sep 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegle Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Carl Schulman, MD, Principal investigator, Ryder Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078385
- Sponsor's protocol ID
- AGLE-102-102
- Status last verified
- Nov 2024
- First submitted
- 12 Oct 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds.
- ClinicalTrials.gov ID
- NCT05078385
- Acronym / sponsor ID
- AGLE-102-102
- Conditions
- Burns
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Aegle TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of patients with deep second degree burns of the skin with extracellular vesicles (EV) isolated from bone marrow derived mesenchymal stem cells.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGLE-102 | Experimental | Drug: AGLE-102AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eighteen years of age or older with deep second degree thermal burn wounds
- Index burn injury within the prior 72 hours
- Subjects must understand and be willing and able to give written informed consent
- Subjects must agree to have blood draws performed per protocol
- Subjects must be accessible for wound treatment and assessment visits
Key exclusion criteria (23 listed)
- Solely first degree or solely third degree burns
- Cumulative burn area ≥ 20% TBSA (20% TBSA corresponds to 3700 cm2 in a 70 kg, 175 cm subject)
- Burns that occur over a previous scar
- Chemical, radiation, or electrical burns
- Subjects with superficial second degree burn who are expected to heal within 2 weeks with standard therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGLE-102AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs) | Drug | AGLE-102 |
Primary outcome
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
2 secondary outcomes
Determine if administration of EVs can promote wound healing by serial wound measurements
Time frame: 8 weeks
Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Schulman, MD principal investigator
Ryder Trauma Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGLE-102 in people with Burns, run by Aegle Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.