Mesenchymal stem cell-derived exosomes: The dawn of diabetic wound healing

Table 2 Clinical trials of exosomes in treating various wounds

Start year	Institution (Nation)	Type of wounds	Intervention	Autologous/Allogeneic	Administration, frequency	Patients number	Follow-up period	Outcome measures	Phase	Study design	ClinicalTrials.gov identifier	Status
2022	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (China)	Full-layer skin wounds	Adipose tissue derived exosomes(200-300 mL of the subject adipose tissue)	Autologous	Applied directly to the wound (mixed with sterile hydrogel), twice a week	5	4 wk	Primary: Percentage of wound healing	Not Applicable	Non-randomized, single group assignment, open label	NCT05475418	Not yet recruiting
2015	Kumamoto University (Japan)	Intractable cutaneous ulcers (e.g., rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns)	Plasma-derived exosomes (Plasma samples will be filtered through 0.45 μm and 0.20 μm filters. The samples will be filtered through 0.02 μm filter to trap exosomes with the filter. Saline solution will be loaded from the other side of the 0.02 μm filter to obtain exosome rich buffer.)	Autologous	Applied to the ulcer, daily	5	28 d	Primary: Ulcer size (length, width, depth)	Early Phase 1	Non-randomized, single group assignment, open label	NCT02565264	Unknown
								Secondary: Pain of cutaneous wounds (VAS)
2023	Aegle Therapeutics (USA)	Dystrophic Epidermolysis Bullosa (DEB); chronic wounds (< 20% closure of wound during observation period); 10-50 cm2	Bone marrow mesenchymal stem cells derived extracellular vesicle (AGLE-102)	Allogeneic	Multiple administrations of 2 ascending dose levels of AGLE-102; (up to 6 administrations); (each administration will occur 14 ± 7 d but no less than 7 d apart); (each administration no more than 3 mo); (wound closes prior to 6 administrations, no additional doses will be given)	10	8 mo; if the wound closes before receiving all 6 doses, for 4 mo after the wound closes	Primary: Dose limiting toxicity	Phase 1/2	Non-randomized, multicenter, ascending dose, single group assignment, open label	NCT04173650	Not yet recruiting
								Secondary: Wound size
2019	Mayapada Hospital (Indonesia)	Chronic wounds	Human Wharton's Jelly mesenchymal stem cells conditioned medium (WJ-MSC-CM)	Allogeneic	Applied to the wound (the conditioned medium gel), every week	38	2 wk	Primary: Success rate of chronic ulcer healing	Phase 1	Non-randomized, single group assignment, open label	NCT04134676	Completed