Safety of Extracellular Vesicles for Burn Wounds

NCT05078385 | Completed Phase 1 FDA Drug

• 1 other identifier: AGLE-102-102
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (2)

• Determine if administration of EVs can promote wound healing by serial wound measurements

  8 weeks

• Laser Doppler will assess differences in dermal perfusion rates between control (unburned) and treated burn tissues.

  1 year

Study Arms (1)

AGLE-102

EXPERIMENTAL

AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs)

Drug: AGLE-102

Interventions

AGLE-102 DRUG

AGLE-102, bone marrow mesenchymal stem cell derived extracellular vesicles (EVs)

AGLE-102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Aegle Therapeutics: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

Ryder Trauma Center

Miami, Florida, 33136, United States

Location

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Carl Schulman, MD

  Ryder Trauma Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 14, 2021
• Study Start: August 10, 2023
• Primary Completion: September 5, 2024
• Study Completion: November 19, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)