NCT05078385

Safety of Extracellular Vesicles for Burn Wounds

Completed Phase 1 Last updated 20 November 2024

What this trial tests

Phase 1 trial testing AGLE-102 in Burns in 1 participant. Completed in 19 November 2024.

Timeline

10 August 2023

Primary endpoint
5 September 2024

19 November 2024

Quick facts

Lead sponsor	Aegle Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	10 August 2023
Primary completion	5 September 2024
Estimated completion	19 November 2024
Sites	2 locations across United States

Drugs / interventions tested

• AGLE-102 — full drug profile →

Conditions studied

• Burns — all drugs for Burns →

Sponsor

Aegle Therapeutics — full company profile →

Who can join

18 and older, any sex, with Burns. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem cell-derived extracellular vesicles for immunomodulation and regeneration: a next generation therapeutic tool?
   Kou M, Huang L, Yang J, Chiang Z, et al · · 2022 · cited 382× · PMID 35787632 · DOI 10.1038/s41419-022-05034-x
2. Exosomes─Nature's Lipid Nanoparticles, a Rising Star in Drug Delivery and Diagnostics.
   Tenchov R, Sasso JM, Wang X, Liaw WS, et al · · 2022 · cited 336× · PMID 36354238 · DOI 10.1021/acsnano.2c08774
3. Extracellular vesicles: a rising star for therapeutics and drug delivery.
   Du S, Guan Y, Xie A, Yan Z, et al · · 2023 · cited 168× · PMID 37475025 · DOI 10.1186/s12951-023-01973-5
4. Mesenchymal stem cell-derived extracellular vesicles in skin wound healing: roles, opportunities and challenges.
   Ding JY, Chen MJ, Wu LF, Shu GF, et al · · 2023 · cited 117× · PMID 37587531 · DOI 10.1186/s40779-023-00472-w
5. Engineering therapeutical extracellular vesicles for clinical translation.
   Ma Y, Dong S, Grippin AJ, Teng L, et al · · 2025 · cited 58× · PMID 39227240 · DOI 10.1016/j.tibtech.2024.08.007
6. Extracellular Vesicles as Therapeutic Resources in the Clinical Environment.
   Sanz-Ros J, Mas-Bargues C, Romero-García N, Huete-Acevedo J, et al · · 2023 · cited 53× · PMID 36768664 · DOI 10.3390/ijms24032344
7. Understanding molecular characteristics of extracellular vesicles derived from different types of mesenchymal stem cells for therapeutic translation.
   Ding Z, Greenberg ZF, Serafim MF, Ali S, et al · · 2024 · cited 34× · PMID 38957857 · DOI 10.1016/j.vesic.2024.100034
8. Mechanisms and clinical application potential of mesenchymal stem cells-derived extracellular vesicles in periodontal regeneration.
   Chen L, Zhu S, Guo S, Tian W. · · 2023 · cited 30× · PMID 36782259 · DOI 10.1186/s13287-023-03242-6